510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2020
DEVICE: MS Lide Implant Systems
Hangzhou Minsheng Lide Medical Sci510(k) NO: K181477(Traditional)
ATTN: Charles Shen PHONE NO :
No.22 Xinyan Road Yuhang Economic SE DECISION MADE: 20-OCT-20
Hangzhou CN 311199 510(k) STATEMENT
DEVICE: Arthrex SoftStitch
Arthrex Inc. 510(k) NO: K190707(Traditional)
ATTN: David L Rogers PHONE NO : 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 02-OCT-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Slow Wave DS8
Slow Wave, Inc. 510(k) NO: K191320(Traditional)
ATTN: Wayne R. Wagner PHONE NO : 281 7875589
26100 Countryside Dr. SE DECISION MADE: 02-OCT-20
Spicewood TX 78669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedCAD® AccuPlan® System
MedCAD 510(k) NO: K192282(Traditional)
ATTN: Brian Buss PHONE NO : 214 4538864 305
501 2nd Ave, Suite A-1000 SE DECISION MADE: 29-OCT-20
Dallas TX 75226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Planmed Clarity 2D and Clarity S
Planmed Oy 510(k) NO: K192317(Traditional)
ATTN: Lars Moring PHONE NO : 358 20 7795300
Sorvaajankatu 7 SE DECISION MADE: 23-OCT-20
Helsinki FI 00880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
Brainlab AG 510(k) NO: K192703(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 89991 5680
Olof-Palme-Str. 9 SE DECISION MADE: 08-OCT-20
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C4 Fiducial Marker
C4 Imaging LLC 510(k) NO: K192771(Traditional)
ATTN: Andrew Bright PHONE NO : 609 9335895
196 West Ashland Street SE DECISION MADE: 21-OCT-20
Doylestown PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BenestaTM Tissue Removal Device
Caldera Medical, Inc. 510(k) NO: K192811(Traditional)
ATTN: Vicki Gail PHONE NO : 818 8796555
5171 Clareton Drive SE DECISION MADE: 23-OCT-20
Agoura Hills CA 91301 510(k) STATEMENT
DEVICE: Zeos Aqua Vision Pump and tube
Hemodia SAS 510(k) NO: K192921(Traditional)
ATTN: Adeline Theron PHONE NO : 33 561007181
France SE DECISION MADE: 09-OCT-20
Labege FR 31670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flower Suture Anchor Set
Flower Orthopedics Corporation 510(k) NO: K192949(Traditional)
ATTN: Jessica Huang PHONE NO : 215 3234018
100 Witmer Rd. Suite 280 SE DECISION MADE: 07-OCT-20
Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Libertas E-XLPE Modular Liner
Maxx Orthopedics, Inc. 510(k) NO: K192989(Traditional)
ATTN: Priscilla Herpai PHONE NO : 484 3420092
2460 General Armistead Ave, Suite SE DECISION MADE: 29-OCT-20
Norristown PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hexanium® ACIF
SpineVision SAS 510(k) NO: K193000(Traditional)
ATTN: Anaelle Gallego PHONE NO : 33 1 53332525
10 rue de la Renaissance Batiment SE DECISION MADE: 20-OCT-20
Antony FR 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive Shoulder System
Biomet Manufacturing Corp. 510(k) NO: K193038(Traditional)
ATTN: Patricia Sandborn Beres PHONE NO : 574 2676639
56 East Bell Drive SE DECISION MADE: 28-OCT-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIB Abutment System
Southern Implants (Pty) Ltd 510(k) NO: K193084(Traditional)
ATTN: Lauranda G Breytenbach PHONE NO : 27 126 671046
1 Albert Road SE DECISION MADE: 27-OCT-20
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxZero Extension Sets with Needle-Free Connector(s)
Carefusion, Inc. 510(k) NO: K193088(Traditional)
ATTN: Viviana Lai PHONE NO : 714 2565345
120 S State College Blvd, Suite 10SE DECISION MADE: 23-OCT-20
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HCG Zirconia Ceramic Block
Hocheng Corporation 510(k) NO: K193090(Traditional)
ATTN: Chieh-Ju Huang PHONE NO : 886 3 3623105 3380
1F.,No.398, Xingshan Rd., Neihu DiSE DECISION MADE: 29-OCT-20
Taipei City TW 11469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nelson Sentinel Series Basic Chlorine Sentinel
Nelson Environmental Technologies,510(k) NO: K193169(Traditional)
ATTN: QuocHuy (Huy) Nquyen PHONE NO : 956 6180375
813 E. Fir Avenue SE DECISION MADE: 29-OCT-20
McAllen TX 78501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WiZARD 510 Nasal Mask
Apex Medical Corp. 510(k) NO: K193206(Traditional)
ATTN: Chieh Yang PHONE NO : 886 2 22685568
No. 9, Min Sheng St. Tu-Cheng. SE DECISION MADE: 29-OCT-20
New Taipei City TW 23679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eCordum Cardiac Monitor (eCordum CM)
eCordum, Inc. 510(k) NO: K193296(Traditional)
ATTN: Vladislav Bukhman PHONE NO : 631 2236447
419 1st Street SE DECISION MADE: 30-OCT-20
East Northport NY 11731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Mix
Inter-Med/ Vista Dental Products 510(k) NO: K193357(Traditional)
ATTN: Katherine Barry PHONE NO : 262 6358956
2220 South Street Suite A SE DECISION MADE: 23-OCT-20
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOZO Body Fluid Analyzer
ImpediMed Limited 510(k) NO: K193410(Traditional)
ATTN: Catherine Kingsford PHONE NO : 61 7 38603700
Unit 1, 50 Parker Court SE DECISION MADE: 02-OCT-20
Pinkenba AU 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Alarm Interface
BoxView, LLC 510(k) NO: K193421(Traditional)
ATTN: Cody Guest PHONE NO : 405 7405785
14001 McAuley Blvd. Suite 220 SE DECISION MADE: 30-OCT-20
Oklahoma City OK 73134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Selectra 3D Outer Guiding Catheters
BIOTRONIK, Inc 510(k) NO: K193474(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 16-OCT-20
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
Bellco Srl 510(k) NO: K193542(Traditional)
ATTN: Rekha Roveri PHONE NO : 39 053529486
Via Camurana 1 SE DECISION MADE: 08-OCT-20
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnovaMatrix
Triad Life Sciences, Inc. 510(k) NO: K193552(Traditional)
ATTN: Russell I Olsen PHONE NO : 901 3336000
1770 Moriah Woods Blvd, Suite 18 SE DECISION MADE: 21-OCT-20
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cryocheck Hex LA
Precision BioLogic 510(k) NO: K193556(Traditional)
ATTN: Karen Black PHONE NO : 902 4686422
140 Eileen Stubbs Avenue SE DECISION MADE: 23-OCT-20
Dartmouth CA B3B 0A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIOnavi-Denture
DIO Corporation 510(k) NO: K193623(Traditional)
ATTN: Jiae Park PHONE NO : 82 51 7457777
66, Centum Seo-ro, Haeundae-gu SE DECISION MADE: 22-OCT-20
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stethee Pro 1, Stethee Pro Software System
M3DICINE Pty Ltd. 510(k) NO: K193631(Traditional)
ATTN: Nayyar Hussain PHONE NO : 61 7 55410034
Level 1, 88 Brandl Street SE DECISION MADE: 09-OCT-20
Eight Mile Plains AU 4113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NP1 Instrument, Creo Electrosurgical System
Creo Medical Ltd. 510(k) NO: K200003(Traditional)
ATTN: Shaun Preston PHONE NO : 44 1291 606005
Creo House, Unit 2, Beaufort Park SE DECISION MADE: 28-OCT-20
Chepstow GB NP16 5UH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neonatal Phototherapy System
Avalon Biomedical (Shenzhen) Limit510(k) NO: K200031(Traditional)
ATTN: Eva Zhu PHONE NO : 86 75521 070534
805 Building 4, Yinxing Zhijie, 13SE DECISION MADE: 05-OCT-20
Longhua District CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUTARS Cemented Femoral Stems
implantcast, GmbH 510(k) NO: K200045(Traditional)
ATTN: Juliane Hoppner PHONE NO : 49 4161 7440
Luneburger Schanze 26 SE DECISION MADE: 16-OCT-20
21614 DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaScope System
Medacta International SA 510(k) NO: K200067(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 01-OCT-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation IBF System
Zavation Medical Products LLC 510(k) NO: K200084(Traditional)
ATTN: Colby Williams PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 19-OCT-20
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: g.Estim FES
g.tec medical engineering GmbH 510(k) NO: K200088(Traditional)
ATTN: Christoph Guger PHONE NO : 43 7251 222400
Siemingerstrasse 14 SE DECISION MADE: 29-OCT-20
Schiedlberg AT 4521 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Abutment Design
3Shape A/S 510(k) NO: K200100(Traditional)
ATTN: Jenny Axel PHONE NO : 45 702 72620
Holmens Kanal 7 SE DECISION MADE: 07-OCT-20
Copenhagen DK 1060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQ Drainage Catheter Set (One Step Type)
Bioteque Corporation 510(k) NO: K200103(Traditional)
ATTN: Stella Hsu PHONE NO : 886 2 25710269 1348
5F-6, No. 23, Sec. 1, Chang’an E. SE DECISION MADE: 09-OCT-20
Taipei City TW 10441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXY-1 System
Abiomed Inc. 510(k) NO: K200109(Traditional)
ATTN: Steve Orwig PHONE NO : 410 4069064
22 Cherry Hill Drive SE DECISION MADE: 23-OCT-20
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astroglide Organix Liquid
BioFilm Inc 510(k) NO: K200114(Traditional)
ATTN: Richard Hines PHONE NO : 760 7279030
3225 Executive Ridge SE DECISION MADE: 13-OCT-20
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermoforming Sheet Materials
Erkodent Erich Kopp GmbH 510(k) NO: K200125(Traditional)
ATTN: Hans-Peter Kopp PHONE NO : 49 744585010
Siemensstrasse 3 SE DECISION MADE: 28-OCT-20
Pfalzgrafenweiler DE 72285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELEGRAPH® EVOLUTION Humeral Nailing System
FH Industrie 510(k) NO: K200127(Traditional)
ATTN: Patricia Donnard PHONE NO : 33 2 98556895
ZI de Kernevez - 6 rue Nobel SE DECISION MADE: 01-OCT-20
Quimper FR 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
Medline Industries Inc 510(k) NO: K200150(Traditional)
ATTN: Leontyne Banks PHONE NO : 224 9311484
Three Lakes Drive SE DECISION MADE: 26-OCT-20
Northfield IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bright Bond Universal
GENOSS Co., Ltd. 510(k) NO: K200153(Traditional)
ATTN: Hong Jun Jeon PHONE NO : 82 70 70987541
1F, Gyeonggi R&DB Center, 105 GwanSE DECISION MADE: 28-OCT-20
Suwon-si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bright Low Flow
Genoss co.,Ltd. 510(k) NO: K200156(Traditional)
ATTN: Hong Jun Jeon PHONE NO : 82____ 70 70987541
1F, Gyeonggi R&DB Center, 105 GwanSE DECISION MADE: 27-OCT-20
Suwon-si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScalpelCric
VBM Medizintechnik GmbH 510(k) NO: K200190(Traditional)
ATTN: Jannika Jaeger PHONE NO : 049 745 495960
Einsteinstrasse 1 SE DECISION MADE: 30-OCT-20
Sulz am Neckar DE 72172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: xPORT S Lens Fragmentation System
Carl Zeiss Meditec Cataract Techno510(k) NO: K200207(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
8748 Technology Way SE DECISION MADE: 15-OCT-20
Reno NV 89521 510(k) STATEMENT
DEVICE: ClearEndoclip
Finemedix Co., Ltd. 510(k) NO: K200217(Traditional)
ATTN: H. S. Lee PHONE NO : 82 053 7418388
60, Maeyeo-ro, Dong-gu SE DECISION MADE: 05-OCT-20
Daegu KR 41065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PocketDoc™ Micro Wound Therapy System
Pensar Medical, LLC 510(k) NO: K200223(Traditional)
ATTN: David Buchicchio PHONE NO : 800 6694757
684 Parkridge Avenue SE DECISION MADE: 23-OCT-20
Norco CA 92860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcutaneous Electronic Nerve Stimulator
Shenzhen Kentro Medical Electronic510(k) NO: K200237(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 755 33825998
No.3, Xihu industry zone, Xikeng VSE DECISION MADE: 19-OCT-20
Longgang District, Shenzhen City 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
Kitazato Corporation 510(k) NO: K200249(Traditional)
ATTN: Futoshi Inoue PHONE NO : 81 545662202
81 Nakajima SE DECISION MADE: 23-OCT-20
Fuji-shi JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEPRINT temp
DETAX GmbH & Co.KG 510(k) NO: K200273(Traditional)
ATTN: Markus Stratmann PHONE NO : 49 724 3510258
Carl-Zeiss-Strasse 4 SE DECISION MADE: 27-OCT-20
Ettlingen DE 76275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses
Pegavision Corporation 510(k) NO: K200296(Traditional)
ATTN: Estela Lin PHONE NO : 886 3 3298808
2F-1, No.5, Shing Yeh St. SE DECISION MADE: 15-OCT-20
Taoyuan TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curos Jet Disinfecting Cap
3M Company 510(k) NO: K200299(Traditional)
ATTN: Cory J Hitzman PHONE NO : 651 7339304
2510 Conway Ave., Bldg. 275-5NW-06SE DECISION MADE: 29-OCT-20
St. Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNiD IB3D ALIF
Medicrea International S.A. 510(k) NO: K200316(Traditional)
ATTN: David Ryan PHONE NO : 33 47 2018787
5389, route de Strasbourg SE DECISION MADE: 30-OCT-20
Rillieux-la-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
Karl Storz Endoscopy-America, Inc.510(k) NO: K200318(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 22-OCT-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoContour
Radformation, Inc. 510(k) NO: K200323(Traditional)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue, 16th floor SE DECISION MADE: 30-OCT-20
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPERT - Joint Fixation System
GM dos Reis Industria e Comercio L510(k) NO: K200332(Traditional)
ATTN: Paula Oliveira PHONE NO : 55____ 19 37659900
Avenida Pierre Simon de La Place 6SE DECISION MADE: 29-OCT-20
Campinas BR 13069320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z5-BL
Z-Systems AG 510(k) NO: K200386(Traditional)
ATTN: Rubino DiGirolamo PHONE NO : 41 62 3886969
Werkhofstrasse 5 SE DECISION MADE: 14-OCT-20
Oensingen CH CH-4702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Shenzhen VitaVitro Biotech Co.,Ltd510(k) NO: K200408(Traditional)
ATTN: Donghai Pan PHONE NO : 86 755 84511813
R601, Building B, Hai Ke Xing TechSE DECISION MADE: 16-OCT-20
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Female Luer Lock Cap
MedSafety Solutions LLC 510(k) NO: K200425(Third Party - Traditional)
ATTN: Rich Weiskopf PHONE NO : 303 5002500
7012 S. Revere Pkwy, Suite 120 SE DECISION MADE: 29-OCT-20
Centennial CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: V20, V20a, AVSM3 SNF
Mediana Co., Ltd. 510(k) NO: K200434(Traditional)
ATTN: Dana Mun PHONE NO : 82 33 7425400
132, Donghwagongdan-ro, Munmak-eupSE DECISION MADE: 09-OCT-20
Wonju-si KR 26365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-DENSE LoVisc Bone Graft Substitute
Wright Medical Technology, Inc. 510(k) NO: K200507(Traditional)
ATTN: Rachel Roberts PHONE NO : 901 8679708
1023 Cherry Road SE DECISION MADE: 21-OCT-20
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-LinkTM X2 ECG Adapter and Leadwires
Vyaire Medical, Inc. 510(k) NO: K200510(Traditional)
ATTN: Suzanne Moreno PHONE NO : 872 7570147
26125 N. Riverwoods Blvd. SE DECISION MADE: 09-OCT-20
Mettawa IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Diamond Diagnostics Inc. 510(k) NO: K200544(Traditional)
ATTN: Kathy Fisher PHONE NO : 508 4290450 358
333 Fiske Street SE DECISION MADE: 01-OCT-20
Holliston MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CellaVision DC-1, CellaVision DC-1 PPA
CellaVision AB 510(k) NO: K200595(Traditional)
ATTN: Magnus Johnsson PHONE NO : 46 46 4601600
Mobilvagen 12 SE DECISION MADE: 16-OCT-20
Lund SE 22362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G21 Cement, VADER® Pedicle System
Icotec AG 510(k) NO: K200596(Traditional)
ATTN: Marina Hess PHONE NO : 41 71 7570024
Industriestrasse 12 SE DECISION MADE: 13-OCT-20
9450 Altstaetten CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OssGuide
Sk bioland Co., Ltd. 510(k) NO: K200623(Traditional)
ATTN: Yeonjeong Chae PHONE NO :
162, Gwahaksaneop 3-ro, Ochang-eupSE DECISION MADE: 02-OCT-20
Cheongju-si KR 28125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
0 & M Halyard, Inc 510(k) NO: K200633(Abbreviated)
ATTN: Steven Dowdley PHONE NO : 678 4518062
5405 Windward Parkway SE DECISION MADE: 11-OCT-20
Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steripath Micro Blood Collection System
Magnolia Medical Technologies Inc.510(k) NO: K200661(Special)
ATTN: Gregory J. Bullington PHONE NO : 1 800 6173420
200 West Mercer Street, Suite 500 SE DECISION MADE: 08-OCT-20
Seattle WA 98119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BZF-29
GC America Inc. 510(k) NO: K200682(Traditional)
ATTN: Mark Heiss PHONE NO : 708 5970900
3737 W. 127th Street SE DECISION MADE: 02-OCT-20
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared PT2L Digital No-Touch Thermometer
Andon Health Co., Ltd. 510(k) NO: K200710(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 8761166092
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 01-OCT-20
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrosurface WristMotion Total Wrist Arthroplasty System
Arthrosurface, Inc. 510(k) NO: K200718(Traditional)
ATTN: Dawn J. Wilson PHONE NO : 508 5203003
28 Forge Parkway SE DECISION MADE: 15-OCT-20
Franklin MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Citregen Tendon Interference Screw and Citrelock
Acuitive Technologies 510(k) NO: K200725(Traditional)
ATTN: Jaclyn Docs PHONE NO : 201 6612678
50 Commerce Drive SE DECISION MADE: 07-OCT-20
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pitkar Sixafix System
S H Pitkar Orthotools Pvt Ltd. 510(k) NO: K200728(Traditional)
ATTN: Vivek Mangalwedhekar PHONE NO : 91 204 0706464
Plot No. EL 32, J Block, MIDC BhosSE DECISION MADE: 06-OCT-20
Pune IN 411026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Foley Catheter with Temperature Sensor
DeRoyal Industries, Inc. 510(k) NO: K200757(Traditional)
ATTN: Sarah Bennett PHONE NO : 865 3626112
200 DeBusk Lane SE DECISION MADE: 15-OCT-20
Powell TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIM Vital, Nerve Integrity Monitor
Medtronic Xomed, Inc. 510(k) NO: K200759(Traditional)
ATTN: Marek Pawlowski PHONE NO : 904 2969600
6743 Southpoint Drive North SE DECISION MADE: 28-OCT-20
Jacksonville FL 32216-0980 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATSTIX
Centrix Incorporated 510(k) NO: K200764(Traditional)
ATTN: Greg Moreau PHONE NO : 203 5677444
770 River Road SE DECISION MADE: 15-OCT-20
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SilverStream Gel
EnzySurge Ltd. 510(k) NO: K200767(Traditional)
ATTN: Moshe Landsberg PHONE NO : 972 3 6227600
26 Shabazi St. SE DECISION MADE: 08-OCT-20
Rosh Ha'Ayin IL 4802126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
L&K BIOMED Co., Ltd. 510(k) NO: K200790(Special)
ATTN: KiHyang Kim PHONE NO : 82 10 54770325
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 28-OCT-20
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
Medacta Inernational SA 510(k) NO: K200792(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91696 6060
Strada Regina SE DECISION MADE: 05-OCT-20
Castel San Pietro CH cH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
L&K BIOMED Co., Ltd. 510(k) NO: K200793(Special)
ATTN: KiHyang Kim PHONE NO : 82 10 54770325
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 08-OCT-20
Giheung-gu, Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd. 510(k) NO: K200794(Special)
ATTN: KiHyang Kim PHONE NO : 82 10 54770325
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 20-OCT-20
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shenzhen Urion Technology Co., Ltd510(k) NO: K200802(Traditional)
ATTN: Autumn Liu PHONE NO : 86 755 29231308
4-6F of Building D, Jiale Science&SE DECISION MADE: 07-OCT-20
Shenzhen CN 518106 510(k) STATEMENT
DEVICE: IPS CaseDesigner
Nobel Biocare AB 510(k) NO: K200810(Traditional)
ATTN: Elena Cavallini PHONE NO : 41 79 29403703
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 08-OCT-20
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URIS OMNI Narrow System & Prosthetic
TruAbutment Inc. 510(k) NO: K200817(Traditional)
ATTN: Eunjin Jang PHONE NO : 714 9561488
17742 Cowan SE DECISION MADE: 07-OCT-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: anti-bacterial bandage
Planet (Suzhou) Medical Products C510(k) NO: K200821(Traditional)
ATTN: Frank Zhou PHONE NO : 86 0512 82181678
No. 33 Qinglian Rd Xuguan IndustriSE DECISION MADE: 19-OCT-20
Suzhou CN 215151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINICONE Implant
Medentika GmbH 510(k) NO: K200906(Traditional)
ATTN: Alexandra Schulz PHONE NO : 49 07229 69912172
Hammweg 8-10 SE DECISION MADE: 16-OCT-20
Huegelsheim DE 76549 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACURA Stabilization System
Indius Medical Technologies Pvt. L510(k) NO: K200937(Traditional)
ATTN: Aditya Ingalhalikar, PHONE NO : 91 8390 873873
Unit No.12, Electronic Co-OperativSE DECISION MADE: 26-OCT-20
Pune IN 411009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® Cohere® Thoracolumbar Interbody System
NuVasive, Incorporated 510(k) NO: K200953(Traditional)
ATTN: Michelle Cheung PHONE NO : 301 9898322
7475 Lusk Blvd. SE DECISION MADE: 06-OCT-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luce Ceramic Bracket
Luce Castle Co., Ltd. 510(k) NO: K201038(Traditional)
ATTN: Kyung Joo Kim PHONE NO :
16, Ojeoncheon-ro, Uiwang SE DECISION MADE: 09-OCT-20
Gyeonggi KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LSN
Imaging Biometrics, LLC 510(k) NO: K201092(Traditional)
ATTN: Timothy Dondlinger PHONE NO : 262 4398252
13416 Watertown Plank Road, Suite SE DECISION MADE: 29-OCT-20
Elm Grove WI 53122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Smoke Evacuation Pencil
Medline Industires, Inc. 510(k) NO: K201129(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
Three Lakes Drive SE DECISION MADE: 16-OCT-20
Northfield IL 60093 510(k) STATEMENT
DEVICE: WEGO-PDO Barbed Suture
Foosin Medical Supplies Inc., Ltd.510(k) NO: K201139(Traditional)
ATTN: Zhipeng Yang PHONE NO : 86 631 5660576
No.20, Xingshan Road, Weihai TorchSE DECISION MADE: 20-OCT-20
Weihai CN 264210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PleurX Peritoneal Catheter System
CareFusion 510(k) NO: K201155(Traditional)
ATTN: Nazeer Khan PHONE NO : 847 3628067
75 North Fairway Drive SE DECISION MADE: 21-OCT-20
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer Model E127
Bioland Technology Ltd. 510(k) NO: K201161(Traditional)
ATTN: Yiqing Feng PHONE NO : 86 755 36900999
No. A6B7 (Block G), ShangRong InduSE DECISION MADE: 02-OCT-20
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encore System
Siesta Medical, Inc. 510(k) NO: K201238(Special)
ATTN: Michael Kolber PHONE NO : 408 5056626
101 Church Street, Suite 3 SE DECISION MADE: 02-OCT-20
Los Gatos CA 95030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Plexus Optix, Inc. 510(k) NO: K201268(Traditional)
ATTN: Dave Delle Donne PHONE NO : 916 8514989
3333 Quality Drive SE DECISION MADE: 21-OCT-20
Rancho Cordova CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X100 with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs LTD. 510(k) NO: K201301(Traditional)
ATTN: Shahar Karny PHONE NO : 972 54 6542164
11 Tiomkin St., 2nd floor SE DECISION MADE: 02-OCT-20
Tel Aviv IL 6578313 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Li-Battery powered OTC TENS/EMS Combination Stimulator
Everyway Medical Instruments Co., 510(k) NO: K201335(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3FL., No.5, Lane 155, Section 3, PSE DECISION MADE: 24-OCT-20
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: ECG Cables and Leadwires
Xinkang Medical Instrument Co., Lt510(k) NO: K201359(Traditional)
ATTN: Xu Changsheng PHONE NO : 86 755 23776681
2 Floor, Puhua Science and TechnolSE DECISION MADE: 01-OCT-20
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
Cordis Corporation 510(k) NO: K201377(Traditional)
ATTN: Luis Davila PHONE NO : 52 656 1707011 04587
14201 NW 60TH Ave SE DECISION MADE: 09-OCT-20
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Livocare Surgical Mask
Andon Health Co., Ltd. 510(k) NO: K201380(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 07-OCT-20
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Avent Single/Double electric breast pump Advanced
Philips Consumer Lifestyle - Innov510(k) NO: K201381(Traditional)
ATTN: Aurore Millet PHONE NO : 0031 618 191888
High Tech Campus 37 SE DECISION MADE: 01-OCT-20
Eindhoven NL 5656 AE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile High-pressure Angiographic Syringes for single-use
Youwo (Guangzhou) Medical Device C510(k) NO: K201395(Traditional)
ATTN: Meijin Song PHONE NO : 86 20817 29108
Kaiyuan Avenue, High-Tech IndustriSE DECISION MADE: 28-OCT-20
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finetest Lite Smart Blood Glucose Monitoring System
OSANG Healthcare Co., Ltd. 510(k) NO: K201396(Special)
ATTN: Ik-Hyeon Kim PHONE NO : 82 31 4600415
132, Anyangcheondong-Ro, Dongan-GuSE DECISION MADE: 16-OCT-20
Anyang KR 14040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINUSPRIME Dilation System
Stryker ENT 510(k) NO: K201398(Traditional)
ATTN: Bruce Backlund PHONE NO : 763 7625902
3600 Holly Lane North, Suite 40 SE DECISION MADE: 15-OCT-20
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vial2Bag Advanced 20mm Admixture Device
West Pharmaceutical Services AZ, I510(k) NO: K201415(Traditional)
ATTN: Elena Mack PHONE NO : 1 610 5943283
14677 North 74th Street SE DECISION MADE: 21-OCT-20
Scottsdale AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trivergent Spinal Fixation System
Benvenue Medical, Inc. 510(k) NO: K201427(Traditional)
ATTN: Laurent Schaller PHONE NO : 408 4549300
4590 Patrick Henry Dr. SE DECISION MADE: 21-OCT-20
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
Arlington Scientific, Inc. (ASI) 510(k) NO: K201438(Traditional)
ATTN: David Binks PHONE NO : 801 4898911
1840 North Technology Dr. SE DECISION MADE: 21-OCT-20
Springville UT 84663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
Edwards Lifesiences, LLC 510(k) NO: K201446(Traditional)
ATTN: Varad Raghuwanshi PHONE NO : 949 7564502
One Edwards Way SE DECISION MADE: 01-OCT-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fortilink Cages with TiPlus Technology
Paradigm Spine, GmbH 510(k) NO: K201453(Traditional)
ATTN: Alberto Jurado PHONE NO :
505 Park Avenue, 14th Floor SE DECISION MADE: 07-OCT-20
New York NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultimate Contour, Ultimate Contour Mini
CAO Group, Inc. 510(k) NO: K201475(Traditional)
ATTN: Robert K. Larsen PHONE NO : 801 2569282
4628 West Skyhawk Drive SE DECISION MADE: 28-OCT-20
West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impression Material
Zhengzhou Huaer Electro Optics Tec510(k) NO: K201483(Traditional)
ATTN: Li XiaoJun PHONE NO : 86 13592 524674
Floor 1, B of Building 18, NationaSE DECISION MADE: 08-OCT-20
Zhengzhou CN 450000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOS Cabling System
Pioneer Surgical Technology, Inc. 510(k) NO: K201497(Traditional)
ATTN: Sarah Pleaugh PHONE NO : 906 2269909
375 River Park Circle SE DECISION MADE: 28-OCT-20
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG App
Apple Inc. 510(k) NO: K201525(Traditional)
ATTN: Luke Olson PHONE NO : 408 6092001
One Apple Park Way SE DECISION MADE: 08-OCT-20
Cupertino CA 94015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yushan X-Ray Flat Panel Detector with DROC
InnoCare Optoelectronics Corp. 510(k) NO: K201528(Traditional)
ATTN: Yumei Cheng PHONE NO : 886 6 7007238 22598
Rm. B, No. 2, Sec. 2, Huanxi Rd., SE DECISION MADE: 11-OCT-20
Tainan City TW 744 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cerament Bone Void Filler
BoneSupport AB 510(k) NO: K201535(Traditional)
ATTN: Blerta Shuka PHONE NO : 46 462865370
Scheelevagen 19, Ideon Science ParSE DECISION MADE: 16-OCT-20
Lund SE SE 223-70 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsOpia Synthetic Bone Void Filler
RevisiOs BV 510(k) NO: K201546(Traditional)
ATTN: Hen Baron PHONE NO : 31 30229 7280
Professor Bronkhorstlaan 10, BuildSE DECISION MADE: 02-OCT-20
3723 MB Bilthoven NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAL for Medical Use(Lower Limb type)
Cyberdyne Inc. 510(k) NO: K201559(Traditional)
ATTN: Yohei Suzuki PHONE NO : 81 29869 8453
2-2-1 Gakuen-Minami SE DECISION MADE: 02-OCT-20
Tsukuba JP 305-0818 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Membrane Screws and Membrane Tacks
Neoss Limited 510(k) NO: K201561(Traditional)
ATTN: Stellan Sundstrom PHONE NO :
Windsor House, Cornwall Rd SE DECISION MADE: 05-OCT-20
Harrogate GB HG1 2PW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spirotrac
Vitalograph Ireland Ltd. 510(k) NO: K201562(Traditional)
ATTN: Tony O'Hanlon PHONE NO : 353 6568 64100
Gort Road Business Park SE DECISION MADE: 14-OCT-20
Ennis Co Clare IE V95 HFT4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPESTRY Biointegrative Implant
Embody, Inc. 510(k) NO: K201572(Traditional)
ATTN: Scott Bruder PHONE NO : 201 8749701
4211 Monarch Way, Ste 500 SE DECISION MADE: 19-OCT-20
Norfolk VA 23508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: icotec Anterior Cervical Plate System
Icotec AG 510(k) NO: K201587(Traditional)
ATTN: Marina Hess PHONE NO : 41 71757 0024
Industriestrasse 12 SE DECISION MADE: 15-OCT-20
Altstaetten CH 9450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merit Hydrophilic Guide Wire
Merit Medical Systems, Inc. 510(k) NO: K201595(Traditional)
ATTN: Mark Mullaney PHONE NO : 353 91 703700 3061
Parkmore Business Park West SE DECISION MADE: 14-OCT-20
Galway IE h91 w274 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IonicRF Generator
Abbott Medical 510(k) NO: K201610(Traditional)
ATTN: Jim Chapman PHONE NO : 651 7565400
5050 Nathan Lane SE DECISION MADE: 21-OCT-20
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA 7.0T
GE Medical Systems, LLC 510(k) NO: K201615(Traditional)
ATTN: Brian R. Zielski PHONE NO : 262 2273596
3200 Grandview Blvd SE DECISION MADE: 15-OCT-20
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Computed Tomography X-Ray System, Green X
Vatech Co., Ltd 510(k) NO: K201627(Traditional)
ATTN: Daniel Kim PHONE NO : 82 31 3799492
13, Samsung 1-ro 2-gil SE DECISION MADE: 27-OCT-20
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KHEIRON® Spinal Fixation System
S.M.A.I.O 510(k) NO: K201659(Traditional)
ATTN: Stephanie Escoffier PHONE NO : 33 469 842802
2, Place Berthe Morisot – Parc TecSE DECISION MADE: 05-OCT-20
Saint-Priest FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YSIO X.pree
Siemens Medical Solutions USA, Inc510(k) NO: K201670(Traditional)
ATTN: Andrew Turner PHONE NO : 610 8505627
40 Liberty Boulevard, 65-1A SE DECISION MADE: 21-OCT-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Instrument Kits
S.I.N. - Sistema de Implante Nacio510(k) NO: K201688(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 21-OCT-20
São Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Modulus XLIF Interbody System
NuVasive, Incorporated 510(k) NO: K201692(Traditional)
ATTN: Jessica LeBlanc PHONE NO : 951 8160973
7475 Lusk Blvd. SE DECISION MADE: 29-OCT-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patent Hemostasis Band (PH Band)
Medical Ingenuities 510(k) NO: K201695(Traditional)
ATTN: Richard "Chip" Corrigan PHONE NO : 630 2582042
345 Browning Court SE DECISION MADE: 30-OCT-20
Wheaton IL 60189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R3 HA Coated Acetabular Shells
Smith & Nephew, Inc. 510(k) NO: K201701(Traditional)
ATTN: John Reabe PHONE NO : 901 3996670
7135 Goodlett Farms Parkway SE DECISION MADE: 06-OCT-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A View LCS
Coreline Soft Co., Ltd. 510(k) NO: K201710(Traditional)
ATTN: Hye Yi Park PHONE NO : 82 2 5717321
4,5F (Yeonnam-dong), 49, World CupSE DECISION MADE: 16-OCT-20
Seoul KR 03991 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pentacam AXL Wave
OCULUS Optikgerate GmbH 510(k) NO: K201724(Traditional)
ATTN: Eckhard Loh PHONE NO : 49 64120050
Munchholzhauser StraBe 29 SE DECISION MADE: 21-OCT-20
Wetzlar DE 35582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
Hartalega SDN BHD 510(k) NO: K201748(Third Party - Traditional)
ATTN: Kuan Kam Hon PHONE NO : 603 62771733
Dataran SD PJU 9 SE DECISION MADE: 02-OCT-20
Bandar Sri Damansara MY 52200 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Voluson E10
GE Healthcare 510(k) NO: K201768(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 22-OCT-20
Wauwatosa WI 53095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Rotatable and Repositionable Hemoclip
Anrei Medical (Hangzhou) Co., Ltd.510(k) NO: K201771(Traditional)
ATTN: Huibing Yang PHONE NO : 86 571 86913333
No.3 Ave. 8, Hangzhou Economic DevSE DECISION MADE: 19-OCT-20
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 31HN713D
LG Electronics Inc. 510(k) NO: K201777(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665441
222, LG-ro, Cheongho-ri, Jinwi-myeSE DECISION MADE: 08-OCT-20
Pyeongtaek-Si KR 17709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
Ossio Ltd. 510(k) NO: K201803(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600
8 HaTochen St. SE DECISION MADE: 16-OCT-20
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: coraForce and coraFlex Support Catheters
Reflow Medical, Inc. 510(k) NO: K201811(Traditional)
ATTN: Krystal Santiago PHONE NO : 949 4810399
208 Avenida Fabricante #100 SE DECISION MADE: 26-OCT-20
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROTAP
Accuro Technologies Inc. 510(k) NO: K201816(Traditional)
ATTN: Michael Dolphin PHONE NO : 1 250 9400015
201-2067 Cadboro Bay Rd SE DECISION MADE: 16-OCT-20
Victoria CA V8R 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nerivio
Theranica Bio-Electronics LTD. 510(k) NO: K201824(Traditional)
ATTN: Alon Ironi PHONE NO : 972 72 3909763
4 Ha-Omanut St. SE DECISION MADE: 23-OCT-20
Netanya IL 4250438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson SWIFT, Voluson SWIFT+
GE Medical Systems Ultrasound and 510(k) NO: K201828(Traditional)
ATTN: Bryan Behn PHONE NO : 262 4701003
9900 Innovation Drive SE DECISION MADE: 11-OCT-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared ear and forehead thermometer, model YI-100
Wenzhou Yosun Medical Technology C510(k) NO: K201843(Traditional)
ATTN: Lihao Yang PHONE NO : 86 577 61896988
No. 17, Shahong Road, Lingmen, BeiSE DECISION MADE: 23-OCT-20
Wenzhou CN 325603 510(k) STATEMENT
DEVICE: Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
Guangzhou Longest Science & Techno510(k) NO: K201845(Traditional)
ATTN: Xiaobing Luo PHONE NO : 86 020 66353999
5 & 6f, Building B4, No. 11, KaiyuSE DECISION MADE: 08-OCT-20
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEON Endoscopic Stapler
Lexington Medical Inc. 510(k) NO: K201882(Traditional)
ATTN: Rainer Maas PHONE NO : 978 2731946
11 Executive Park Drive SE DECISION MADE: 09-OCT-20
Billerica MA 01862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
Microline Surgical, Inc. 510(k) NO: K201884(Traditional)
ATTN: Scott Marchand Davis PHONE NO : 978 9229810
50 Dunham Road, Suite 1500 SE DECISION MADE: 21-OCT-20
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON Testosterone xt
DiaSorin Inc. 510(k) NO: K201908(Special)
ATTN: John Walter PHONE NO : 651 4399710
1951 Northwestern Avenue SE DECISION MADE: 15-OCT-20
Stillwater MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Piccolo Composite Proximal Tibia Plate System
CarboFix Orthopedics, Ltd. 510(k) NO: K201917(Traditional)
ATTN: Yael Rubin PHONE NO : 972 9 9511511
11 Ha’hoshlim St SE DECISION MADE: 08-OCT-20
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAIA Lumbar Interbody Fusion Device (LIFD) Family
PrinterPrezz 510(k) NO: K201939(Traditional)
ATTN: Kishore Karkera PHONE NO : 510 2258412
4110 Clipper CT SE DECISION MADE: 08-OCT-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Skeletal Dynamics Ulnar Shortening Plating System
Skeletal Dynamics, Inc. 510(k) NO: K201962(Traditional)
ATTN: Diana Taylor PHONE NO : 303 5967585
7300 N. Kendall Drive, Suite 400 SE DECISION MADE: 13-OCT-20
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Schoelly Cystoscopes/Hysteroscopes and Accessories
Schoelly Fiberoptic GmbH 510(k) NO: K201970(Traditional)
ATTN: Sandra Baumann PHONE NO : 49 7666 9080
Robert-Bosch-Str. 1-3 SE DECISION MADE: 08-OCT-20
Denzlingen DE D-79211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
Canon Medical Systems Corporation 510(k) NO: K201972(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 08-OCT-20
Otawara-Shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
Med-El Elektromedizinische Geraete510(k) NO: K201983(Traditional)
ATTN: Stephanie Haselwanter PHONE NO : 43 577885622
Fuerstenweg 77a SE DECISION MADE: 09-OCT-20
Innsbruck AT 6020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Lite
Sonoscanner 510(k) NO: K201988(Traditional)
ATTN: Bruno Richard PHONE NO : 33 954 971557
6 rue Andre Voguet SE DECISION MADE: 30-OCT-20
Ivry Sur Seine FR 94200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Glove
Better Health Medical Products Co.510(k) NO: K202010(Traditional)
ATTN: Xiaomeng Li PHONE NO : 86 533 3819144
Zhangliu Road, Zhangdian District SE DECISION MADE: 16-OCT-20
Zibo CN 255087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRDensity by Whiterabbit.ai
Whiterabbit.ai Inc. 510(k) NO: K202013(Traditional)
ATTN: Jason Su PHONE NO : 914 2751097
3930 Freedom Cir. Ste 101 SE DECISION MADE: 30-OCT-20
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dall-Miles® Cable System
Howmedica Osteonics Corp., dba Str510(k) NO: K202016(Traditional)
ATTN: Margaret Klippel PHONE NO : 201 8315559
325 Corporate Drive SE DECISION MADE: 16-OCT-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OASIS MRI System
Hitachi Healthcare Americas 510(k) NO: K202030(Traditional)
ATTN: Aaron Pierce PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 21-OCT-20
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opera Evo
Quanta System SpA 510(k) NO: K202041(Traditional)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
Via Acquedotto 109 SE DECISION MADE: 15-OCT-20
Samarate IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powerpress Recovery Unit
Hanuri Distribution, Inc 510(k) NO: K202044(Traditional)
ATTN: Jung Hyun Moon PHONE NO : 818 9981023
9601 Owensmouth Ave. # 8 SE DECISION MADE: 21-OCT-20
Chatsworth CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLOMITE Anterior Cervical Stabilization System
Astura Medical, LLC 510(k) NO: K202065(Traditional)
ATTN: Parker Kelch PHONE NO : 469 5015530
4949 W Royal Ln. SE DECISION MADE: 26-OCT-20
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIPHOR Wound Irrigation System
Orthophor, LLC 510(k) NO: K202071(Traditional)
ATTN: Alan Miller PHONE NO : 215 8011590
125 S. 9th Street Sheridan BuildinSE DECISION MADE: 23-OCT-20
Philadelphia PA 19107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
Bonraybio Co., Ltd. 510(k) NO: K202089(Special)
ATTN: Brown Hsu PHONE NO : 88 64 24912385
4F., No.118, Gongye 9th Rd. Dali DSE DECISION MADE: 28-OCT-20
Taichung TW 41280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
Neocis Inc. 510(k) NO: K202100(Traditional)
ATTN: Thomas E Claiborne PHONE NO : 631 7938945
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 19-OCT-20
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoMed ExtremiFix Mini & Small System Tray
OsteoMed LLC 510(k) NO: K202105(Traditional)
ATTN: Andrew Johnson PHONE NO : 972 6774768
3885 Arapaho Road SE DECISION MADE: 29-OCT-20
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20
Bolder Surgical, LLC 510(k) NO: K202114(Third Party - Traditional)
ATTN: Nicholas Wong PHONE NO : 720 2877130
331 S. 104th Street, Suite 200 SE DECISION MADE: 06-OCT-20
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AcuSee AS-P1000 System
Weipeng (Suzhou) Medical Devices C510(k) NO: K202119(Traditional)
ATTN: Bin Yang PHONE NO : 85 0512 67311267
Unit 207, Building B2, Biobay, 218SE DECISION MADE: 07-OCT-20
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sleepware G3
Respironics, Inc. 510(k) NO: K202142(Traditional)
ATTN: Jonquil Mau PHONE NO : 724 3877442
1001 Murry Ridge Lane SE DECISION MADE: 29-OCT-20
Murrysville PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextAR TKA Platform
Medacta International SA 510(k) NO: K202152(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 27-OCT-20
Castel San Pietro CH ch-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
Smith & Nephew Medical Limited 510(k) NO: K202157(Traditional)
ATTN: Steeve Lamvohee PHONE NO : 44 482 683195
101 Hessle Road SE DECISION MADE: 30-OCT-20
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiverMultiScan
Perspectum LTD 510(k) NO: K202170(Traditional)
ATTN: Jaco Jacobs PHONE NO : 44 018 65655343
Gemini One, 5520 John Smith Drive SE DECISION MADE: 02-OCT-20
Oxford GB OX4 2LL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
Medline Industries, Inc. 510(k) NO: K202179(Traditional)
ATTN: Adam Ostrower PHONE NO : 224 9311513
Three Lakes Drive SE DECISION MADE: 26-OCT-20
Northfield IL 60093 510(k) STATEMENT
DEVICE: Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001
Axess Vision Technology 510(k) NO: K202180(Third Party - Traditional)
ATTN: Marie-Hélène Bacheley PHONE NO : 33 02 47343290
Zone de la Liodière 6, rue de la FSE DECISION MADE: 22-OCT-20
Joué-lès-Tours FR 37300 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Oculus-SA Lumbar Cage System
Neurostructures 510(k) NO: K202190(Traditional)
ATTN: Moti Altarac PHONE NO : 800 3526103
199 Technology Drive, Suite 110 SE DECISION MADE: 02-OCT-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
S.B.M. SAS (Science & Bio Material510(k) NO: K202193(Special)
ATTN: Anne Cospin-Latapie PHONE NO : 33 562 422101
Zi Du Monge SE DECISION MADE: 16-OCT-20
Lourdes FR 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise PKA Guide System
Materialise NV 510(k) NO: K202207(Traditional)
ATTN: Veerle Vanderheyden PHONE NO : 32 16 744571
Technologielaan 15 SE DECISION MADE: 02-OCT-20
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Neuro Perfusion
Siemens Medical Solutions USA, Inc510(k) NO: K202213(Traditional)
ATTN: Veronica Padharia PHONE NO : 630 8775761
2501 N. Barrington Rd. SE DECISION MADE: 11-OCT-20
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
Boston Scientific Corporation 510(k) NO: K202218(Traditional)
ATTN: Vanessa Fowler PHONE NO : 763 4942537
3 Scimed Place SE DECISION MADE: 02-OCT-20
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruForm Sievers Annuloplasty Ring
Genesee BioMedical, Inc 510(k) NO: K202253(Traditional)
ATTN: Woodrow Mathison PHONE NO : 303 7773000
700 W Mississippi Ave, Unit D5 SE DECISION MADE: 06-OCT-20
Denver CO 80223-4509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
Parcus Medical, LLC 510(k) NO: K202259(Traditional)
ATTN: Paul Vagts PHONE NO : 1 941 7557965
6423 Parkland Drive SE DECISION MADE: 28-OCT-20
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cleerly Labs v2.0
Cleerly, Inc. 510(k) NO: K202280(Traditional)
ATTN: James K. Min PHONE NO : 646 3624255
101 Greenwich St, Suite 11C SE DECISION MADE: 02-OCT-20
New York NY 10006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ENfit OTC Feeding Syringe
Medline Industries, Inc. 510(k) NO: K202285(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 09-OCT-20
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UDE
EBM Technologies Inc. 510(k) NO: K202292(Traditional)
ATTN: John Su PHONE NO : 886 2 87514567 356
5F., No. 516, Sec. 1, Neihu Rd. SE DECISION MADE: 05-OCT-20
Taipei TW 114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radiographic System Challenge X
Sedecal, SA. 510(k) NO: K202293(Abbreviated)
ATTN: Mª Luisa Gómez de Agüero PHONE NO : 34 91 6280544
C/ Pelaya, 9 -13 Pol. Ind. Rio de SE DECISION MADE: 07-OCT-20
Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affirm Contrast Biopsy
Hologic, Inc 510(k) NO: K202294(Special)
ATTN: Kate Brown PHONE NO : 203 7027873
36 Apple Ridge Road SE DECISION MADE: 05-OCT-20
Danbury CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atlas Spine Rebar (Ti) Spacer System
Atlas Spine, Inc. 510(k) NO: K202302(Traditional)
ATTN: Thomas Smith PHONE NO : 561 7411108
1555 Jupiter Park Drive, Suite 1 SE DECISION MADE: 30-OCT-20
Jupiter FL 33458 510(k) STATEMENT
DEVICE: Zavation IBF System
Zavation Medical Products, LLC 510(k) NO: K202305(Traditional)
ATTN: Colby Williams PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 13-OCT-20
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System
Zimmer Biomet Spine, Inc. 510(k) NO: K202309(Traditional)
ATTN: David Pollard PHONE NO : 303 2560053
10225 Westmoor Drive SE DECISION MADE: 08-OCT-20
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus™ OsseoScrew® System
Alphatec Spine, Inc. 510(k) NO: K202327(Traditional)
ATTN: Sandy Gill PHONE NO : 760 4946740
5818 El Camino Real SE DECISION MADE: 15-OCT-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Droplet Pen Needle 30G & 33G
HTL-Strefa S.A. 510(k) NO: K202340(Traditional)
ATTN: Aleksandra Prazmowska-WilanPHONE NO : 48 42 2700016
Adamowek 7 SE DECISION MADE: 15-OCT-20
Ozorkow PL 95-035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cartesion Prime, PCD-1000A, V10.7
Canon Medical Systems Corporation 510(k) NO: K202349(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 15-OCT-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nutricare Clear-ISOSAF Nasogastric Feeding Tube
Three Circles Consulting Limited 510(k) NO: K202357(Traditional)
ATTN: Matthew Theobald PHONE NO : 44 1782 955255
MED IC4, Keele University Science SE DECISION MADE: 01-OCT-20
Keele GB ST5 5NL 510(k) STATEMENT
DEVICE: Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
Canon Medical Systems Corporation 510(k) NO: K202364(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 15-OCT-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
Shenzhen Beacon Display Technology510(k) NO: K202374(Traditional)
ATTN: Fu Ailing PHONE NO : 86 0755 36868363 5150
12F, Block B1, Nanshan Zhiyuan, NoSE DECISION MADE: 19-OCT-20
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIR-Spheres Microspheres Activity Calculator (SMAC)
Sirtex Medical US Holdings Inc. 510(k) NO: K202392(Traditional)
ATTN: Michael P. Hanley PHONE NO : 781 7213828
300 Unicorn Park, 2nd Fl. SE DECISION MADE: 23-OCT-20
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineJack Expansion Kit
Stryker Corporation 510(k) NO: K202393(Traditional)
ATTN: Kristi Ashton PHONE NO : 269 8001692
1926 Stryker Way SE DECISION MADE: 20-OCT-20
Kalamazoo MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Lumenis Ltd. 510(k) NO: K202428(Special)
ATTN: Shlomit Segman PHONE NO : 972 4 9599230
6 Hakidma Street PO Box 240 SE DECISION MADE: 22-OCT-20
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobio Total Knee System
b-One Ortho, Corp. 510(k) NO: K202429(Traditional)
ATTN: Allison Gecik PHONE NO : 973 5878431
3 Wing Drive Suite #259 SE DECISION MADE: 23-OCT-20
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-EYE System
SMART Medical Systems Ltd. 510(k) NO: K202469(Traditional)
ATTN: Adva Yoselzon PHONE NO : 972 9 7444321
5 HaNofar Street SE DECISION MADE: 26-OCT-20
Raanana IL 4366404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIS Duofix Hip Prosthesis
DePuy Orthopaedics Inc. 510(k) NO: K202472(Special)
ATTN: Karen Mahoney PHONE NO : 508 8283704
700 Orthopaedic Drive SE DECISION MADE: 21-OCT-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
Boston Scientific Corporation 510(k) NO: K202478(Special)
ATTN: Stephanie Gorman PHONE NO : 508 6835692
100 Boston Scientific Way SE DECISION MADE: 08-OCT-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
Advanced Orthopaedic Solutions, In510(k) NO: K202489(Traditional)
ATTN: Jolie Krance PHONE NO : 310 5339966
3203 Kashiwa Street SE DECISION MADE: 26-OCT-20
Torrance CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTHEM Fracture System
Globus Medical Inc. 510(k) NO: K202496(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armistead Ave. SE DECISION MADE: 29-OCT-20
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aulisa Multiple Patient Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Tech510(k) NO: K202497(Traditional)
ATTN: Paul Liu PHONE NO : 886 2 26557297 221
Rm. 1052, Bldg. H, 10F., No.32, YSE DECISION MADE: 30-OCT-20
Taipei City TW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantib Prostate
Quantib BV 510(k) NO: K202501(Traditional)
ATTN: Floor van Leeuwen PHONE NO : 31 108 411749
Westblaak 106 SE DECISION MADE: 11-OCT-20
Rotterdam NL 3012 KM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoNext Platform System
Orthofix Srl 510(k) NO: K202519(Traditional)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
Via Delle Nazioni, 9 SE DECISION MADE: 27-OCT-20
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cannulated Power Driver Attachment
K2M Inc. 510(k) NO: K202528(Traditional)
ATTN: Megan Callanan PHONE NO : 551 2622429
600 Hope Parkway SE SE DECISION MADE: 26-OCT-20
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nutriglide(TM) Nasal Feeding Tube
Applied Medical Technology, Inc. 510(k) NO: K202539(Traditional)
ATTN: Joy Tubero PHONE NO : 440 7174000
8006 Katherine Blvd. SE DECISION MADE: 29-OCT-20
Brecksville OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS30 Diagnostic Ultrasound System
Samsung Medison Co., LTD 510(k) NO: K202556(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
3366, Hanseo-ro, Nam-myeon, SE DECISION MADE: 30-OCT-20
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Workstation 12" Elite
Spectrum Medical Ltd 510(k) NO: K202557(Special)
ATTN: Colleen Powell PHONE NO : 44 01242 387082
Harrier 4, Meteor Business Park, CSE DECISION MADE: 02-OCT-20
Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSleeve Introducer Set
Boston Scientific Corporation 510(k) NO: K202584(Special)
ATTN: Kripa Pandya PHONE NO : 612 2424046
Three Scimed Place SE DECISION MADE: 06-OCT-20
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)
Stryker 510(k) NO: K202592(Special)
ATTN: Divya Sekar PHONE NO : 669 2044851
5900 Optical Ct SE DECISION MADE: 08-OCT-20
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instrument Clamps Electromagnetic
Stryker Corporation 510(k) NO: K202609(Special)
ATTN: Maya Schiel PHONE NO : 49 30 31191189
Boetzinger Strasse 41 SE DECISION MADE: 09-OCT-20
Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScanX Edge
Dürr Dental SE 510(k) NO: K202633(Special)
ATTN: Oliver Lange PHONE NO : 49 07142 7050
Höpfigheimer Str. 17 SE DECISION MADE: 07-OCT-20
Bietigheim-Bissingen DE 74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visera Elite II Video System Center
Olympus Medical Systems Corp. 510(k) NO: K202646(Special)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 29-OCT-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
Ethicon Endo-Surgery, LLC 510(k) NO: K202665(Special)
ATTN: Nathan Anderson PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 15-OCT-20
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTRUX Mini PTC Spacer System
Orthofix Inc. 510(k) NO: K202666(Special)
ATTN: Natalia Volosen PHONE NO : 214 9372145
3451 Plano Parkway SE DECISION MADE: 14-OCT-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoMed ExtremiFix Mini & Small Cannulated Screw System
OsteoMed LLC 510(k) NO: K202680(Special)
ATTN: Andrew "Drew" Johnson PHONE NO : 972 6774768
3885 Arapaho Road SE DECISION MADE: 15-OCT-20
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
Siemens Medical Solutions, USA, In510(k) NO: K202683(Special)
ATTN: Christine Dunbar PHONE NO : 925 3742045
22010 S.E. 51st Street SE DECISION MADE: 15-OCT-20
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1212FCA
Rayence Co., Ltd 510(k) NO: K202722(Special)
ATTN: Kee Dock Kim PHONE NO : 82 31 80156459
14, Samsung 1-ro 1-gil SE DECISION MADE: 26-OCT-20
Hwaseong-si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Ventilation Module
Spectrum Medical Ltd 510(k) NO: K202733(Special)
ATTN: Colleen Powell PHONE NO : 44 01242 387082
Harrier 4, Meteor Business Park, CSE DECISION MADE: 16-OCT-20
Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System
Canon Medical Systems Corporation 510(k) NO: K202737(Special)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 16-OCT-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic Knee System Tibial Inserts, PS-Max
Total Joint Orthopedics, Inc. 510(k) NO: K202740(Special)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 09-OCT-20
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
CooperVision, Inc. 510(k) NO: K202756(Special)
ATTN: Marie Dutton PHONE NO : 925 6604474
6101 Bollinger Canyon Road, Suite SE DECISION MADE: 20-OCT-20
San Ramon CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iridex 810 Laser
Iridex Corporation 510(k) NO: K202760(Special)
ATTN: Bill Hyatt PHONE NO : 650 9404700
1212 Terra Bella Ave. SE DECISION MADE: 21-OCT-20
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon Spinal System
Medtronic 510(k) NO: K202771(Special)
ATTN: Raphael McInnis PHONE NO : 901 3992057
1800 Pyramid Pl SE DECISION MADE: 19-OCT-20
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Drakon and Sequre Microcatheters
Accurate Medical Therapeutics Ltd.510(k) NO: K202797(Special)
ATTN: Osnat Harbater PHONE NO : 972 54 3386871
19 Eli Hurvitz Street SE DECISION MADE: 23-OCT-20
Rehovot IL 7608802 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA15
Palliare Ltd. 510(k) NO: K202799(Special)
ATTN: John O'Dea PHONE NO : 353 91 516362
Galway Business Park, Dangan SE DECISION MADE: 21-OCT-20
Galway IE H91 P2DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEO Bone Screw System
Gramercy Extremity Orthopedics, LL510(k) NO: K202817(Special)
ATTN: Michael Simpson PHONE NO : 855 4362278
1239 N. Glenville Dr. SE DECISION MADE: 22-OCT-20
Richardson TX 75081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tri-Staple 2.0 Reloads
Covidien 510(k) NO: K202864(Special)
ATTN: Carolina Cabezas PHONE NO : 203 4926054
60 Middletown Avenue SE DECISION MADE: 28-OCT-20
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IlluminOss Bone Stabilization System
IlluminOss Medical, Inc. 510(k) NO: K202887(Special)
ATTN: Robert Rabiner PHONE NO : 401 7140008
993 Waterman Avenue SE DECISION MADE: 27-OCT-20
East Providence RI 02914 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wiltrom Spinal Fixation System
Wiltrom Corporation Limited 510(k) NO: K202894(Special)
ATTN: Freda Lin PHONE NO : 866 3 6107168
1F., No. 26, Sec. 2, Shengyi Rd. SE DECISION MADE: 23-OCT-20
Zhubei City TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longeviti ClearFit Cranial Implant
Longeviti Neuro Solutions, LLC 510(k) NO: K202901(Special)
ATTN: Heather Hourihan PHONE NO : 410 5271803
303 International Circle Suite 190SE DECISION MADE: 30-OCT-20
Hunt Valley MD 21030 510(k) STATEMENT
DEVICE: ARIX Ankle Distal Tibia System
Jeil Medical Corporation 510(k) NO: K202912(Special)
ATTN: Ahhyeon Woo PHONE NO : 82 2 8503591
702,703,704,705,706,804,805,807,81SE DECISION MADE: 29-OCT-20
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syntec Femoral Nail Extended System
Syntee Scientific Corporation 510(k) NO: K202935(Special)
ATTN: Nicole Tseng PHONE NO : 886 4 7987099
No.2, Kung San Road Chuan Shing InSE DECISION MADE: 28-OCT-20
Chang Hua TW 50971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap Caiman 5 Seal and Cut Technology System
Aesculap Inc. 510(k) NO: K202938(Special)
ATTN: Omunique (Nikki) Luke PHONE NO : 484 5236868
3773 Corporate Parkway SE DECISION MADE: 30-OCT-20
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzOrtho
Ewoo Soft Co., Ltd. 510(k) NO: K202948(Special)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 22-OCT-20
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTRUX Mini PEEK Spacer System
Orthofix Inc. 510(k) NO: K202949(Special)
ATTN: Natalia Volosen PHONE NO : 214 9372145
3451 Plano Parkway SE DECISION MADE: 29-OCT-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Video Cysto-Urethroscope (C-view)
KARL STORZ Endoscopy-America, Inc 510(k) NO: K202957(Special)
ATTN: Winkie Wong PHONE NO : 310 6583427
2151 E. Grand Avenue SE DECISION MADE: 29-OCT-20
EI Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: General Cutting Contra Handpiece
Nakanishi Inc. 510(k) NO: K202960(Special)
ATTN: Masaaki Kikuchi PHONE NO : 81 289 647277
700 Shimohnata SE DECISION MADE: 27-OCT-20
Kanuma JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mazor X
Mazor Robotics Ltd. 510(k) NO: K203005(Special)
ATTN: Shiran Conforti PHONE NO : 972 4 6187100
5 Shacham St. North Industrial ParSE DECISION MADE: 27-OCT-20
Caesarea IL 3079567 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eKuore Pro Series
Chip Ideas Electronics S.L. 510(k) NO: K203007(Third Party - Traditional)
ATTN: Bernardo Plaza Trillo PHONE NO : 0034 961 156738
Calle Alfareria 3 B SE DECISION MADE: 30-OCT-20
Burjasot ES 46100 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FUJIFILM Distal End Cap
Fujifilm Corporation 510(k) NO: K203028(Special)
ATTN: Randy Vader PHONE NO : 360 356 6821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 30-OCT-20
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CloudVue
International Medical Solutions In510(k) NO: K203058(Third Party - Traditional)
ATTN: Vernon Colaco PHONE NO : 1 949 2329298
2425 Matheson Blvd E SE DECISION MADE: 29-OCT-20
Mississauga CA L4W 5K4 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Triathlon PKR System
Howmedica Osteonics Corp aka Stryk510(k) NO: K203099(Traditional)
ATTN: Allison Byrne PHONE NO : 201 8315969
325 Corporate Dr. SE DECISION MADE: 27-OCT-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 246
TOTAL WITH SUMMARIES 234
TOTAL WITH STATEMENTS 12
