510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2020
DEVICE: Sweden & Martina Surgical Tray (Model "ZSHORTY-INT")
Sweden & Martina S.p.A. 510(k) NO: K182084(Traditional)
ATTN: Alessia Pezzato PHONE NO : 39 049 9124300
via Veneto 10 SE DECISION MADE: 04-NOV-20
Due Carrare IT 35020 510(k) STATEMENT
DEVICE: JTK Dental Implant System
Jiangyin Jintech Biotech Co., Ltd.510(k) NO: K183044(Traditional)
ATTN: Jie Zhang PHONE NO : 0086 510 68823671
Building D1, No.6 Dongshengxi RoadSE DECISION MADE: 10-NOV-20
Jiangyin City CN 214437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILON® XO Shoulder Replacement System
Implantcast GmbH 510(k) NO: K191433(Traditional)
ATTN: Juliane Hoppner PHONE NO : 49 4161 7440
Lueneburger Schanze 26 SE DECISION MADE: 12-NOV-20
Buxtehude DE 21614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palm NRG cellulite and muscle toning body device
Heat In A Click 510(k) NO: K191940(Traditional)
ATTN: Guy Levi PHONE NO : 954 5189777
1975 Tigertail Blvd Dania SE DECISION MADE: 03-NOV-20
Homestead FL 33034 510(k) STATEMENT
DEVICE: SysMed S/T
SysMed (China) Co., Ltd 510(k) NO: K192177(Traditional)
ATTN: Yue Jian PHONE NO : 86 2423 970169
11-2-3 No. 17 Wensu Str., Hunnan NSE DECISION MADE: 25-NOV-20
Shenyang CN 110171 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPR Face Shield
Firstar Healthcare Company Limited510(k) NO: K192285(Traditional)
ATTN: Alice Zhao PHONE NO : 86 20 39026210 6001
Rm.901, Building No.2,HeadquartersSE DECISION MADE: 25-NOV-20
Guangzhou CN 511400 510(k) STATEMENT
DEVICE: AveCure BT Microwave Ablation System
MedWaves, Inc. 510(k) NO: K192406(Traditional)
ATTN: Theodore Ormsby PHONE NO : 760 8071000
16760 West Bernardo Drive SE DECISION MADE: 25-NOV-20
San Diego CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GM501 Wash with Phenol Red and Gentamicin
Hamilton Thorne Incorporated 510(k) NO: K192503(Special)
ATTN: Donald Fournier PHONE NO : 1 978 9212050
100 Cummings Center, Suite 465E SE DECISION MADE: 19-NOV-20
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kerecis Gingiva Graft
Kerecis Limited 510(k) NO: K192612(Traditional)
ATTN: Gudmundur Fertram SigurjonssPHONE NO : 354 5622 2601
Eyrargata 2 SE DECISION MADE: 13-NOV-20
Isafjordur IS 400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: e-Motion M25
Alber GmbH 510(k) NO: K192618(Traditional)
ATTN: Michael Vent PHONE NO : 49 7432 20060
Vor dem Weissen Stein 21 SE DECISION MADE: 02-NOV-20
Albstadt DE 72461 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical RF
Triworks Group SRL 510(k) NO: K192621(Traditional)
ATTN: Elio Piero Berchicci PHONE NO : 39 0874 1896435
Via L.Belpulsi 3 SE DECISION MADE: 06-NOV-20
Campobasso IT 86100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire Infusion Pump, Sapphire administration sets
Q Core Medical Ltd. 510(k) NO: K192860(Traditional)
ATTN: Guy Mlechkovich PHONE NO : 972 732388 803
29 Yad Haruzim St. SE DECISION MADE: 19-NOV-20
Netanya IL 4250529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpeediCath Compact Set
Coloplast 510(k) NO: K192904(Traditional)
ATTN: Michael Bumgarner PHONE NO : 612 2630488
1601 West River Road North SE DECISION MADE: 02-NOV-20
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOGas 4 Ethylene Oxide Gas Sterilizer
Andersen Sterilizers, Inc. 510(k) NO: K192978(Traditional)
ATTN: William K. Andersen PHONE NO : 336 3768622
3154 Caroline Drive SE DECISION MADE: 12-NOV-20
Haw River NC 27258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOGas 4 Endo-SteriTest
Andersen Sterilizers, Inc. 510(k) NO: K192980(Traditional)
ATTN: William K. Andersen PHONE NO : 336 3768622
3154 Caroline Drive SE DECISION MADE: 12-NOV-20
Haw River NC 27258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liebel-Flarsheim IBP Transfer Set
Liebel-Flarsheim Company LLC 510(k) NO: K193010(Traditional)
ATTN: Alice Lorenzo PHONE NO : 856 9060019
1034 South Brentwood Blvd, Suite 8SE DECISION MADE: 18-NOV-20
Richmond Heights MO 63117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Puritan Bennett 980 Series Ventilator System
Covidien, LLC 510(k) NO: K193056(Traditional)
ATTN: Zheng Liu PHONE NO : 760 2774867
6135 Gunbarrel Ave SE DECISION MADE: 20-NOV-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
Nipro Renal Solutions USA, Corp. 510(k) NO: K193155(Traditional)
ATTN: Vincent DeGrandchamp PHONE NO : 717 9388391 117
509 Fishing Creek Road SE DECISION MADE: 25-NOV-20
Lewisberry PA 17339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACENT™ Central Venous Catheter
Global Medikit Limited 510(k) NO: K193158(Traditional)
ATTN: Mahendra Singh PHONE NO : 91 11 27667889
Khasra No 323 MI, Camp Road, SelaqSE DECISION MADE: 24-NOV-20
Dehradun IN 248197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PureHub Disinfecting Cap
Becton, Dickinson and Company 510(k) NO: K193190(Traditional)
ATTN: Samhitha Mohan PHONE NO : 201 8475204
1 Becton Drive SE DECISION MADE: 09-NOV-20
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
Weinmann Emergency Medical Technol510(k) NO: K193191(Traditional)
ATTN: Kristin Ratschiller PHONE NO : 49 40 881896 0
Frohbösestraße 12 SE DECISION MADE: 20-NOV-20
Hamburg DE 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Telio CAD Abutment Solutions- extra systems
Ivoclar Vivadent, AG 510(k) NO: K193193(Abbreviated)
ATTN: Sandra Cakebread PHONE NO : 423 235 3535
Bendererstrasse 2 SE DECISION MADE: 16-NOV-20
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
Biomet Inc. 510(k) NO: K193214(Traditional)
ATTN: Janine Kem PHONE NO : 574 3710578
56 East Bell Drive SE DECISION MADE: 10-NOV-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-ONESTEP
Vitromed GmbH 510(k) NO: K193285(Traditional)
ATTN: Deepesh Changat PHONE NO : 49 36 4153976
Hans-Knöll-Str. 6 SE DECISION MADE: 20-NOV-20
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorInsights MRI
ADM Diagnostics, Inc. 510(k) NO: K193287(Traditional)
ATTN: Dawn C. Mathews PHONE NO : 847 7070370
555 Skokie Boulevard, Suite 500 SE DECISION MADE: 20-NOV-20
Northbrook IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FastStroke, CT Perfusion 4D
GE Medical Systems SCS 510(k) NO: K193289(Traditional)
ATTN: Elizabeth Mathew PHONE NO : 262 4247774
283 rue de la Miniere SE DECISION MADE: 12-NOV-20
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROView
GE Medical Systems SCS 510(k) NO: K193306(Traditional)
ATTN: Hong Cui PHONE NO : 1 262 5068238
3000 North Grandview Boulevard-HQ SE DECISION MADE: 17-NOV-20
Waukesha WI 53188-1696 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Codman Surgical Patties & Strips
Integra LifeSciences Corporation 510(k) NO: K193346(Traditional)
ATTN: Alyssa Woodcock PHONE NO : 508 6157426
11 Cabot Boulevard SE DECISION MADE: 20-NOV-20
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TopLock Anchor System
Fusion Orthopedics, LLC 510(k) NO: K193377(Traditional)
ATTN: Kolby Black PHONE NO : 800 4036876
4135 S. Power Rd. Suite 110 SE DECISION MADE: 25-NOV-20
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TP Orthodontics Clear Aligner System
TP Orthodontics Inc. 510(k) NO: K193385(Traditional)
ATTN: Stephanie Thyen PHONE NO : 219 7852591
100 Center Plaza SE DECISION MADE: 12-NOV-20
La Porte IN 46350-9672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O2asis Personal Oxygen Humidifier
Perma Pure LLC 510(k) NO: K193411(Traditional)
ATTN: Sidra Hankins PHONE NO : 732 2440010
1001 New Hampshire Ave SE DECISION MADE: 12-NOV-20
Lakewood NJ 08701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage PSI System
3D Systems 510(k) NO: K193432(Traditional)
ATTN: Kim Torluemke PHONE NO : 720 6431001
5381 South Alkire Circle SE DECISION MADE: 09-NOV-20
Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigiGuide System
ProtoMED, Inc. 510(k) NO: K193499(Traditional)
ATTN: James Jimenez PHONE NO : 303 4665610
1329 W 121st Ave SE DECISION MADE: 04-NOV-20
Westminster CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc510(k) NO: K193562(Traditional)
ATTN: Lauren Bentley PHONE NO : 1610 2416736
40 Liberty Blvd. Mail Code 65-3 SE DECISION MADE: 06-NOV-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K193576(Traditional)
ATTN: Helen Chow PHONE NO : 949 3588437
9775 Toledo Way SE DECISION MADE: 20-NOV-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
Dongguan E-Test Technology Co., Lt510(k) NO: K193621(Traditional)
ATTN: Victor Wan PHONE NO : 86 769811 58038
Room 201, 301. Building 1, ChangpiSE DECISION MADE: 23-NOV-20
Dongguan CN 523588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Concinnity Aligners
Drake Precision Dental Laboratory 510(k) NO: K200005(Traditional)
ATTN: Robert Savage PHONE NO : 704 8452401
8510 Crown Crescent Ct SE DECISION MADE: 09-NOV-20
Charlotte NC 28227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse DermaFlex Cannula
Eclipse MedCorp, LLC 510(k) NO: K200017(Traditional)
ATTN: John Tepper PHONE NO :
5916 Stone Creek Drive Suite#120 SE DECISION MADE: 05-NOV-20
The Colony TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Beacon Submucosal Injectable Solution
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K200071(Traditional)
ATTN: Sally He PHONE NO : 86 2558 646395
NO. 10 Gaoke Third Road SE DECISION MADE: 03-NOV-20
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioMin Restore Plus
Dr. Collins, Inc. 510(k) NO: K200077(Traditional)
ATTN: Jiahe Li PHONE NO : 949 5526334
4330 Barranca Pkwy. Ste #100 SE DECISION MADE: 06-NOV-20
Irvine CA 92604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUWAVE Microwave Ablation System and Accessories
NeuWave Medical, Inc. 510(k) NO: K200081(Traditional)
ATTN: Dan Kosednar PHONE NO : 608 2169902
3529 Anderson Street SE DECISION MADE: 13-NOV-20
Madison WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VagiVital Aktivgel
Peptonic Medical AB 510(k) NO: K200098(Traditional)
ATTN: Dan Markusson PHONE NO : 46 530 20110
Gustavslundsvagen 143 SE DECISION MADE: 10-NOV-20
Bromma SE 16751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bright High Flow
GENOSS Co., Ltd. 510(k) NO: K200155(Traditional)
ATTN: Hong Jun Jeon PHONE NO : 82 70 70987541
1F, Gyeonggi R&DB Center, 105 GwanSE DECISION MADE: 30-NOV-20
Suwon-si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mirus Ligating Clip, Mirus Ligating Clip Applier
M/s. Meril Endo Surgery Private Li510(k) NO: K200166(Traditional)
ATTN: Umesh Sharma PHONE NO : 91 26030 52100 3811
Third Floor , E1-E3, Meril Park, SSE DECISION MADE: 23-NOV-20
Chala, Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMR TT Augmented Glenoid System
LimaCorporate S.p.A 510(k) NO: K200171(Traditional)
ATTN: Michela Zanotto PHONE NO : 39 04329 45511
Via Nazionale 52 SE DECISION MADE: 19-NOV-20
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astroglide Organix Gel
BioFilm Inc. 510(k) NO: K200239(Traditional)
ATTN: Richard Hines PHONE NO : 760 7279030
3225 Executive Ridge SE DECISION MADE: 13-NOV-20
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AN1036 Dosimeter
Andersen Sterilizers, Inc. 510(k) NO: K200334(Traditional)
ATTN: William K Andersen PHONE NO : 336 3768622
3154 Caroline Drive SE DECISION MADE: 12-NOV-20
Haw River NC 27258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterisheet Sterilization Wrap
Andersen Sterilizers, Inc. 510(k) NO: K200335(Traditional)
ATTN: William K Andersen PHONE NO : 336 3768622
3154 Caroline Drive SE DECISION MADE: 12-NOV-20
Haw River NC 27258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyvek Sterilization Pouches with Chevron Seal
Andersen Sterilizers, Inc. 510(k) NO: K200336(Traditional)
ATTN: William K Andersen PHONE NO : 336 3768622
3154 Caroline Drive SE DECISION MADE: 12-NOV-20
Haw River NC 27258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyHip Planner & Verifier
Medacta International SA 510(k) NO: K200350(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 04-NOV-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil
Modern Medical Equipment Manufactu510(k) NO: K200372(Traditional)
ATTN: Jerry Cheung PHONE NO : 852 242 09068
Flat A, 11/F., Mai Wah Ind. Bldg.,SE DECISION MADE: 30-NOV-20
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apogee
Incoba Ltd. d/b/a Dynaris 510(k) NO: K200401(Traditional)
ATTN: Lon Aylsworth PHONE NO : 636 7781926
Spirit 40 Park Dr., Suite 260 SE DECISION MADE: 14-NOV-20
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR-HO'S Electro Therapy Conductive Gel
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K200402(Traditional)
ATTN: Sammy Li PHONE NO : 86 020 66393598
23 Building, Phase-II, Huachuang ISE DECISION MADE: 25-NOV-20
Guangzhou CN 511450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Drive Interference Screw System
Nvision Biomedical Technologies, I510(k) NO: K200428(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 10-NOV-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freeprint denture
Detax GmbH & Co. KG 510(k) NO: K200461(Traditional)
ATTN: Markus Stratmann PHONE NO : 49 7243 510258
Carl-Zeiss-Strasse 4 SE DECISION MADE: 16-NOV-20
Ettlingen DE 76275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viveve System
Viveve Medical, Inc. 510(k) NO: K200472(Traditional)
ATTN: Kevin Robison PHONE NO : 317 4358898
345 Inverness Drive South, BuildinSE DECISION MADE: 18-NOV-20
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO® 3 EP Navigation System with Signal Processing Unit
Biosense Webster, Inc. 510(k) NO: K200484(Traditional)
ATTN: Khaled Hamad PHONE NO : 949 4536350
33 Technology Drive SE DECISION MADE: 25-NOV-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FotoDent denture
Dreve Dentamid GmbH 510(k) NO: K200580(Abbreviated)
ATTN: Reiner Altmann PHONE NO : 49 2303880714
Max-Planck-Strasse 31 SE DECISION MADE: 19-NOV-20
Unna DE 59423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
Sorin Group Italia S.r.l. 510(k) NO: K200612(Traditional)
ATTN: Luigi Vecchi PHONE NO : 39 0535 29957
Via statale 12 Nord, 86 SE DECISION MADE: 17-NOV-20
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Durex Penck Standard, Durex Penck XL
RB Health (US) LLC 510(k) NO: K200672(Traditional)
ATTN: Kyle Prince PHONE NO : 973 4042600
399 Interpace Parkway SE DECISION MADE: 06-NOV-20
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K2 MOBILE
HULASER, Inc. 510(k) NO: K200693(Traditional)
ATTN: InBae Park PHONE NO : 82 2 30125678
1110, Daerung Technotown 17, 25, GSE DECISION MADE: 19-NOV-20
Seoul KR 08594 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sientra OPUS Silicone Gel Breast Implant Sizer
Sientra, Inc 510(k) NO: K200706(Traditional)
ATTN: JoAnn Kuhne PHONE NO : 805 5623500
420 South Fairview Avenue, Suite 2SE DECISION MADE: 16-NOV-20
Santa Barbara CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuro.Al Algorithm
TeraRecon, Inc. 510(k) NO: K200750(Special)
ATTN: Megha Jain PHONE NO : 650 3721100
4309 Emperor Blvd., Suite 310 SE DECISION MADE: 06-NOV-20
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tenax Laser Resistant Endotracheal Tube
Bryan Medical, Inc. 510(k) NO: K200761(Traditional)
ATTN: Andrew J. Georgilis PHONE NO : 513 2721600
5725 Dragon Way, Suite 300 SE DECISION MADE: 25-NOV-20
Cincinnati OH 45227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-CEM ONE
GC America Inc. 510(k) NO: K200798(Traditional)
ATTN: Mark Heiss PHONE NO : 708 9263090
3737 W. 127th Street SE DECISION MADE: 24-NOV-20
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas u 701 microscopy analyzer
Roche Diagnostics 510(k) NO: K200811(Traditional)
ATTN: Teresa Carrow PHONE NO : 317 5212963
9115 Hague Road SE DECISION MADE: 06-NOV-20
Indianapolis IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpeediCath Compact Set
Coloplast 510(k) NO: K200820(Traditional)
ATTN: Michael Bumgarner PHONE NO : 612 2630488
1601 West River Road North SE DECISION MADE: 13-NOV-20
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO
NICo-Lab B.V. 510(k) NO: K200873(Traditional)
ATTN: Merel Boers PHONE NO : 003 1202440852
Paasheuvelweg 25 SE DECISION MADE: 20-NOV-20
Amsterdam NL 1105BP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimSite
Allotrope Medical Inc 510(k) NO: K200886(Traditional)
ATTN: Albert Huang PHONE NO : 832 7998546
2450 Holcombe Blvd., Suite J SE DECISION MADE: 10-NOV-20
Houston TX 77021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freedom(R) - TiNbN Coated Knee
Maxx Orthopedics, Inc. 510(k) NO: K200912(Traditional)
ATTN: Priscilla Herpai PHONE NO : 484 3420092
2460 General Armistead Ave, Suite SE DECISION MADE: 18-NOV-20
Norristown PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RF Surgical Generator
Fulwell LLC 510(k) NO: K200931(Traditional)
ATTN: Perla Melisa Mcliberty PHONE NO : 1 305 5353568
3411 NW 48 Street SE DECISION MADE: 24-NOV-20
Miami FL 33142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Dental Implant System
S.I.N.-Sistema de Implante Naciona510(k) NO: K200992(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 17-NOV-20
Sao Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genius AI Detection
Hologic, Inc. 510(k) NO: K201019(Traditional)
ATTN: Deborah Thomas PHONE NO : 508 2106107
250 Campus Drive SE DECISION MADE: 18-NOV-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cordiana Dx16
Cordiana Medical Informatics AG 510(k) NO: K201060(Traditional)
ATTN: Johan Sandberg PHONE NO : 41 41 5345638
Platz 4 SE DECISION MADE: 16-NOV-20
Root CH 6039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Print splint
VOCO GmbH 510(k) NO: K201091(Traditional)
ATTN: M. Th. Plaumann PHONE NO : 49 47217190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 06-NOV-20
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: NeuroStar Advanced Therapy
Neuronetics, Inc. 510(k) NO: K201158(Traditional)
ATTN: Gary Johnson PHONE NO : 610 9814138
3222 Phoenixville Pike SE DECISION MADE: 20-NOV-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Guard
EnvisionTEC GmbH 510(k) NO: K201173(Traditional)
ATTN: Ruediger van Bernum PHONE NO : 49 2043 987545
Brusseler Strabe 51 SE DECISION MADE: 27-NOV-20
Gladbeck DE D-45968 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System
SeaSpine Orthopedics Corporation 510(k) NO: K201193(Traditional)
ATTN: Alicia McArthur PHONE NO : 760 2165122
5770 Armada Drive SE DECISION MADE: 25-NOV-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via MI Workflows, syngo MBF
Siemens Medical Solutions USA, Inc510(k) NO: K201195(Traditional)
ATTN: Clayton Ginn PHONE NO : 865 8982692
2501 N. Barrington Road SE DECISION MADE: 18-NOV-20
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accula Strep A Test
Mesa Biotech, Inc. 510(k) NO: K201269(Dual Track)
ATTN: Barbara Stevens PHONE NO : 858 7355043
6190 Cornerstone Court, Suite 220 SE DECISION MADE: 09-NOV-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Guangdong Long Yao Electronic Tech510(k) NO: K201294(Traditional)
ATTN: Lei Wang PHONE NO : 86 13580 508450
Unit A03, 2nd Floor, No. 19, HualiSE DECISION MADE: 27-NOV-20
Guangzhou CN 510000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axonpen, Axonmonitor, Axonbox, Tablet
ClearMind Biomedical 510(k) NO: K201308(Traditional)
ATTN: Sheng-Chi Lin PHONE NO : 886 2226 97417
5f, No 167, Fuxing N. Rd., SongshaSE DECISION MADE: 27-NOV-20
Taipei TW 105021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optomed Smartscope M5 with Optomed Smartscope FA
Optomed Oyj 510(k) NO: K201325(Traditional)
ATTN: Jyri Leskelä PHONE NO : 358 20 7413380
Yrttipellontie 1 SE DECISION MADE: 20-NOV-20
Oulu FI 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
de Gotzen S.r.l. 510(k) NO: K201382(Abbreviated)
ATTN: Dario Bandiera PHONE NO : 39 0331 376760
Via Roma, 45 SE DECISION MADE: 18-NOV-20
Olgiate Olona IT 21057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Passio Pump Drainage System
Bearpac Medical 510(k) NO: K201404(Traditional)
ATTN: Jay Zimmerman PHONE NO : 603 6825710
124 West Point Road SE DECISION MADE: 20-NOV-20
Moultonborough NH 03254 510(k) STATEMENT
DEVICE: OGYILI TENS/NMES Stimulator
Gongguan Tutamen Metalwork Co., LT510(k) NO: K201431(Traditional)
ATTN: Charles Shen PHONE NO : 086 769 87989845
No.2, HuangGouTang Rd, Shahu, TangSE DECISION MADE: 09-NOV-20
Dongguan CN 523001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Somnos Anti-Snoring Mouth Guard
Koncept Innovators, LLC. 510(k) NO: K201484(Traditional)
ATTN: Sylvan Newby PHONE NO : 843 9454031
1619 Executive Ave SE DECISION MADE: 23-NOV-20
Myrtle Beach SC 29577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sharps container
Zhejiang Gongdong Medical Technolo510(k) NO: K201523(Traditional)
ATTN: Weifeng Zhong PHONE NO : 86 57684 051777
No.10, Beiyuan Avenue, Huangyan SE DECISION MADE: 12-NOV-20
Taizhou CN 318020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIPCAM1 Rubina Video Endoscope System
Karl Storz Endoscopy America 510(k) NO: K201526(Traditional)
ATTN: Mario Trujillo PHONE NO : 424 2188184
2151 E. Grand Ave SE DECISION MADE: 20-NOV-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calvary Spine Pedicle Screw System
Calvary Spine, LLC 510(k) NO: K201568(Traditional)
ATTN: James Edwards PHONE NO :
308 North Wind Road SE DECISION MADE: 12-NOV-20
Towson MD 21204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Shanghai Kindly Medical Instrument510(k) NO: K201601(Traditional)
ATTN: Xu Jianhai PHONE NO : 86 21 59140056
No. 925, Jinyuan yi Road, ShanghaiSE DECISION MADE: 10-NOV-20
Shanghai CN 201803 510(k) STATEMENT
DEVICE: Medical surgical mask
Guangdong KINGFA Sci.&Tech.Co.,Ltd510(k) NO: K201622(Traditional)
ATTN: Yu Xiaoge PHONE NO : 86 2632 8999
28 Delong Avenue, Shijiao Town, QiSE DECISION MADE: 24-NOV-20
Qingyuan CN 511500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compex Sport Elite 3.0
DJO, LLC 510(k) NO: K201653(Traditional)
ATTN: Michael Davis PHONE NO : 205 7898154
1430 Decision Street SE DECISION MADE: 27-NOV-20
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE MANOMETER
Flexicare Medical Limited 510(k) NO: K201666(Traditional)
ATTN: Joel Biddle PHONE NO : 44 1443 474560
Cynon Valley Business Park SE DECISION MADE: 13-NOV-20
Mountain Ash GB cf45 4er 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimpleSENSE
Nanowear Inc. 510(k) NO: K201669(Traditional)
ATTN: Venkatesh Varadan PHONE NO : 718 6374815
53 Boerum Place, Suite 3F SE DECISION MADE: 06-NOV-20
Brooklyn NY 11201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMMA Block
Huge Dental Material Co., Ltd. 510(k) NO: K201683(Traditional)
ATTN: Maggie Zheng PHONE NO : 086 633 2277285
Middle Shanhai Road SE DECISION MADE: 03-NOV-20
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avenda Health Treatment System
Avenda Health, Inc. 510(k) NO: K201687(Traditional)
ATTN: Brittany Berry-Pusey PHONE NO : 310 9575202
929 Colorado Ave SE DECISION MADE: 30-NOV-20
Santa Monica CA 90401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Therapy Device
Shenzhen Dongjilian Electronics Co510(k) NO: K201694(Traditional)
ATTN: Zhang Hong PHONE NO : 86 755 89964118
B1/1-5F, Tonglu Industrial Area, TSE DECISION MADE: 19-NOV-20
Shenzhen CN 518116 510(k) STATEMENT
DEVICE: Gabriel 3 Way EnFit Valve
Syncro Medical Innovations, Inc. 510(k) NO: K201741(Traditional)
ATTN: Sabry Gabriel PHONE NO : 478 3358311
515 Mulberry Street SE DECISION MADE: 05-NOV-20
Macon GA 31201-6308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eKuore One Wireless Electronic Interface for stethoscope
Chip Ideas Electronics S.L 510(k) NO: K201742(Traditional)
ATTN: Bernardo Plaza Trillo PHONE NO : 0034 961 156738
Calle Alfareria 3 B SE DECISION MADE: 24-NOV-20
Burjasot ES 46100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dornier MAGELLAN Ureteral Access Sheath
Dornier MedTech America Inc 510(k) NO: K201815(Traditional)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts Blvd, Suite 100 SE DECISION MADE: 20-NOV-20
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiniCAT 2D
Xoran Technologies LLC 510(k) NO: K201825(Traditional)
ATTN: Mark McGarrow PHONE NO : 734 4185125
5210 S. State Rd. SE DECISION MADE: 20-NOV-20
Ann Arbor MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GR-17 Resin System
Pro3dure Medical GmbH 510(k) NO: K201827(Traditional)
ATTN: Martin Klare PHONE NO : 49 02374 920050 11
Am Burgberg 13 SE DECISION MADE: 05-NOV-20
Iserlohn DE 58642 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Rebound Therapeutics 510(k) NO: K201840(Traditional)
ATTN: Naomi Gong PHONE NO : 949 5236510
13900 Alton Parkway Suite 120 SE DECISION MADE: 04-NOV-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
Baxter Healthcare Corporation 510(k) NO: K201867(Traditional)
ATTN: Brad Roynon PHONE NO : 262 5817157
25212 W. Illinois Route 120 SE DECISION MADE: 19-NOV-20
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OtoSet- Ear Cleaning System
SafKan, Inc. 510(k) NO: K201877(Traditional)
ATTN: Sahil Diwan PHONE NO : 253 3329770
1665 E 18th Street #205 SE DECISION MADE: 05-NOV-20
Tucson AZ 85719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoroFlow Cardiovascular System
Coroventis Research AB 510(k) NO: K201881(Traditional)
ATTN: Johan Svanerud PHONE NO : 0046 70970 3100
Ulls Vag 29A SE DECISION MADE: 13-NOV-20
Uppsala SE 75651 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MammaPrint
Agendia Inc. 510(k) NO: K201902(Traditional)
ATTN: Marcelo Trevino PHONE NO : 310 4097828
22 Morgan SE DECISION MADE: 05-NOV-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monet Curing Laser
CAO Group, Inc. 510(k) NO: K201904(Traditional)
ATTN: Robert K. Larsen PHONE NO : 801 2569282
4628 West Skyhawk Drive SE DECISION MADE: 24-NOV-20
West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOS Large Fragment Plating System
Smith & Nephew, Inc. 510(k) NO: K201918(Traditional)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
1450 E Brooks Rd SE DECISION MADE: 16-NOV-20
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceramir Restore QuikCap
Doxa Dental AB 510(k) NO: K201937(Abbreviated)
ATTN: Anna-Lisa Tiensuu PHONE NO : 46 1847 82000
Axel Johanssons Gata 4-6 SE DECISION MADE: 13-NOV-20
Uppsala SE 75450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monitor B125, Monitor B105
GE Medical Systems Information Tec510(k) NO: K201941(Traditional)
ATTN: Joel Kent PHONE NO : 262 3581082
8200 West Tower Avenue SE DECISION MADE: 04-NOV-20
Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SnapshotNIR
Kent Imaging 510(k) NO: K201976(Traditional)
ATTN: Liz Newell PHONE NO : 403 4557610
804B 16th Ave SW SE DECISION MADE: 10-NOV-20
Calgary CA t2r 0s9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPS 3 ND Myocardial Protection System
Quest Medical, Inc. 510(k) NO: K201984(Traditional)
ATTN: Tosan Eweka PHONE NO : 972 3326338
One Allentown Parkway SE DECISION MADE: 20-NOV-20
Allen TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KardiaAI
AliveCor, Inc. 510(k) NO: K201985(Traditional)
ATTN: Saket Bhatt PHONE NO : 650 3968553
444 Castro Street, Suite 600 SE DECISION MADE: 12-NOV-20
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System
Shenzhen Mindray Bio-medical Elect510(k) NO: K201990(Traditional)
ATTN: Jiang Haosen PHONE NO : 86 755 81886183
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 09-NOV-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical surgical mask
Shenzhen Everwin Precision Technol510(k) NO: K201991(Traditional)
ATTN: Guoshun Shi PHONE NO : 86 139 25511162
Block A&B&C, NCBC Industrial Park,SE DECISION MADE: 23-NOV-20
Shenzhen CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETi AIO Peripheral Thrombectomy System
Walk Vascular, LLC 510(k) NO: K201998(Traditional)
ATTN: David Look PHONE NO : 949 7529642
17171 Daimler Street SE DECISION MADE: 17-NOV-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silatrix Oral Gel
SA3, LLC 510(k) NO: K202000(Traditional)
ATTN: Farbod Melamed PHONE NO : 310 2828086
2317 Cotner Ave SE DECISION MADE: 20-NOV-20
Los Angeles CA 90064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vscan Air
GE Medical Systems Ultrasound and 510(k) NO: K202035(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
Primary Care Diagnostics, LLC 9900SE DECISION MADE: 20-NOV-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Innovative Health, LLC. 510(k) NO: K202042(Special)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 20-NOV-20
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
Abbott Medical 510(k) NO: K202066(Traditional)
ATTN: Alyssa Timmers PHONE NO : 651 7563706
One St. Jude Medical Drive SE DECISION MADE: 25-NOV-20
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apache Ultrasound System (Model C62)
Compal Electronics, Inc. 510(k) NO: K202074(Traditional)
ATTN: DK Lee PHONE NO : 886 3 5820446
No. 581, 581-1, Ruiguang Rd., NeihSE DECISION MADE: 12-NOV-20
Taipei City TW 11492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Physiq
El. En. Electronic Engineering SPA510(k) NO: K202079(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 25-NOV-20
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
Molnlycke Health Care, US LLC 510(k) NO: K202090(Traditional)
ATTN: Leonard Stewart PHONE NO : 678 4516072
5445 Triangle Parkway, Suite 400 SE DECISION MADE: 22-NOV-20
Peachtree Corners GA 30092 510(k) STATEMENT
DEVICE: GLOBAL UNITE™ Platform Shoulder System
DePuy Ireland UC 510(k) NO: K202098(Traditional)
ATTN: Karen Mahoney PHONE NO :
Loughbeg, Ringaskiddy SE DECISION MADE: 25-NOV-20
Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venue
GE Medical Systems Ultrasound and 510(k) NO: K202132(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 13-NOV-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical surgical mask
Guangdong Kingfa SCI.&Tech.Co., Lt510(k) NO: K202139(Traditional)
ATTN: Yu Xiaoge PHONE NO : 86 135 70952157
28 Delong Avenue, Shijiao Town, QiSE DECISION MADE: 20-NOV-20
Qingyuan CN 511500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlidePath 7.5F Long-Term Dialysis Catheter
C.R. Bard, Inc. 510(k) NO: K202150(Traditional)
ATTN: Joan Bergstrom PHONE NO : 480 5978425
1625 W. Third Street SE DECISION MADE: 18-NOV-20
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StarWalker
Fotona d.o.o. 510(k) NO: K202172(Traditional)
ATTN: Anja Pucer PHONE NO : 386 1 5009274
Stegne 7 SE DECISION MADE: 19-NOV-20
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaLoop Anchor System
T.A.G. Medical Products Corporatio510(k) NO: K202178(Traditional)
ATTN: Shlomi Dines PHONE NO : 97 249 858400
Gaaton SE DECISION MADE: 13-NOV-20
Gaaton IL 2513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
DePuy Ireland UC 510(k) NO: K202194(Traditional)
ATTN: Erin Combs PHONE NO : 574 3727211
Loughbeg Ringaskiddy SE DECISION MADE: 25-NOV-20
Co. Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlareHawk Interbody Fusion System
Integrity Implants Inc. 510(k) NO: K202198(Traditional)
ATTN: Lauren Kamer PHONE NO : 561 5293861
354 Hiatt Drive SE DECISION MADE: 03-NOV-20
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venue Go
GE Medical Systems Ultrasound and 510(k) NO: K202233(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 18-NOV-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY-PHI System with SPY-PHI Fluorescence Assessment Software
Novadaq Technologies ULC (now a pa510(k) NO: K202244(Traditional)
ATTN: Agatha Szeliga PHONE NO : 604 4227516
8329 Eastlake Drive, Unit 101 SE DECISION MADE: 05-NOV-20
Burnaby CA V5A 4W2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermatological Carbon Dioxide Laser Systems
Zhuolu Jontelaser Manufacturing Te510(k) NO: K202250(Traditional)
ATTN: Karen Liu PHONE NO : 86 139 11459627
No. 31, Sanguanmiao Alley, Zhuolu SE DECISION MADE: 25-NOV-20
Zhangjiakou CN 072750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-MILLED Abutment
MIT Global Co., Ltd. 510(k) NO: K202269(Traditional)
ATTN: Lim Rok Won PHONE NO : 82 31 7452838
474 Dunchon-daero, Jungwon-gu SE DECISION MADE: 25-NOV-20
Seongnam-si KR 13229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
Nalu Medical, Inc. 510(k) NO: K202274(Traditional)
ATTN: Michele Chin-Purcell PHONE NO : 760 4482360
2320 Faraday Ave. Suite 100 SE DECISION MADE: 09-NOV-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 Platform software
Etiometry, Inc. 510(k) NO: K202306(Traditional)
ATTN: Tim Hanson PHONE NO : 857 3669333
280 Summer St. 4th Floor SE DECISION MADE: 25-NOV-20
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Activ Fuse
Newclip Technics 510(k) NO: K202307(Traditional)
ATTN: Gaelle Lussori PHONE NO : 33 2 28213712
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 17-NOV-20
Haute-Goulaine FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
Everyway Medical Instruments Co., 510(k) NO: K202317(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3FL., No. 5, Lane 155, Section 3, SE DECISION MADE: 13-NOV-20
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
Beckman Coulter, Inc. 510(k) NO: K202343(Traditional)
ATTN: Elaine Duncan PHONE NO : 916 3743279
1584 Enterprise Blvd. SE DECISION MADE: 16-NOV-20
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TiUltra Implants and Xeal Abutments
Nobel Biocare AB 510(k) NO: K202344(Traditional)
ATTN: Bernice Jim PHONE NO : 41 79 8550073
Box 5190, SE-402 26 SE DECISION MADE: 16-NOV-20
Vastra Hamngatan 1 SE 411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Omega PEEK Knotless Anchor System
Stryker 510(k) NO: K202355(Traditional)
ATTN: Katie Farraro PHONE NO : 408 4647396
5900 Optical Ct. SE DECISION MADE: 13-NOV-20
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ion Endoluminal System
Intuitive Surgical, Inc. 510(k) NO: K202370(Traditional)
ATTN: Jyoti Singh PHONE NO : 408 4313527
1266 Kifer Road SE DECISION MADE: 16-NOV-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX 3D Total Ankle Replacement System
Paragon 28, Inc. 510(k) NO: K202373(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 13-NOV-20
Englewood CA 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Global Fever Panel External Control Kit
BioFire Defense, LLC 510(k) NO: K202382(Traditional)
ATTN: Cynthia Phillips PHONE NO : 801 2623592 1370
79 West 4500 South, Suite 14 SE DECISION MADE: 20-NOV-20
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC ResinCal PC
S&C Polymer Silicon- und Composite510(k) NO: K202413(Traditional)
ATTN: Christian Bottcher PHONE NO : 0049 4121 4830
Robert-Bosch-Str. 2 SE DECISION MADE: 20-NOV-20
Elmshorn DE 25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
Kimberly Clark Corporation 510(k) NO: K202416(Traditional)
ATTN: Juan Marquez PHONE NO : 1 678 3526069
1400 Holcomb Bridge Road SE DECISION MADE: 30-NOV-20
Roswell GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arietta 65
Hitachi Healthcare Americas 510(k) NO: K202422(Traditional)
ATTN: Aaron Pierce PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 04-NOV-20
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aqueduct 100 Plus Cervical Dilation Balloon Catheter
GTIMD LLC 510(k) NO: K202427(Special)
ATTN: Eran Levit PHONE NO : 603 8093089
6 Columbia Drive SE DECISION MADE: 06-NOV-20
Amherst NH 03031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carewear Firefly Wrinkle Reduction
Carewear Corp. 510(k) NO: K202442(Traditional)
ATTN: Patrick Parker PHONE NO : 888 9888797
1225 Financial Blvd. SE DECISION MADE: 19-NOV-20
Reno NV 89502 510(k) STATEMENT
DEVICE: Knotless TensionTight Button Implant System
Arthrex Inc. 510(k) NO: K202444(Special)
ATTN: Jessica Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 17-NOV-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
Medline Industries, Inc. 510(k) NO: K202449(Traditional)
ATTN: Jennifer Mason PHONE NO :
Three Lakes Drive SE DECISION MADE: 18-NOV-20
Northfield IL 60093 510(k) STATEMENT
DEVICE: Night Guard
3D Diagnostix Inc. 510(k) NO: K202465(Traditional)
ATTN: Ehab Amin PHONE NO : 1 617 8205279
24 Denby Road SE DECISION MADE: 25-NOV-20
Allston MA 02134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
Everyway Medical Instruments Co., 510(k) NO: K202470(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3FL., No. 5, Lane 155, Section 3, SE DECISION MADE: 25-NOV-20
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
Heraeus Medical GmbH 510(k) NO: K202475(Traditional)
ATTN: Yannick Nils Hermanns PHONE NO : 49 6181 352818
Philipp-Reis-Str. 8/13 SE DECISION MADE: 23-NOV-20
Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Salvo® Spine System
Spine Wave, Inc. 510(k) NO: K202476(Traditional)
ATTN: Amy Noccioli PHONE NO : 203 9449494
Three Enterprise Drive, Suite 210 SE DECISION MADE: 05-NOV-20
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avid CT2
Vision Quest Industries Inc./dba V510(k) NO: K202490(Traditional)
ATTN: Mohamed Ouerghi PHONE NO : 760 6910168
1390 Decision Street, Suite A SE DECISION MADE: 16-NOV-20
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chrome
Quanta System Spa 510(k) NO: K202503(Traditional)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
via Acquedotto, 109 SE DECISION MADE: 18-NOV-20
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVO Implant System – NUVO Instrument Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K202515(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 24-NOV-20
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
ProSomnus Sleep Technologies, Inc.510(k) NO: K202529(Special)
ATTN: Divya Mavalli PHONE NO : 925 3077069
5860 West Las Positas Blvd. SE DECISION MADE: 20-NOV-20
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FastThread Interference Screw
Arthrex Inc. 510(k) NO: K202535(Special)
ATTN: Jessica L. Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 18-NOV-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Midas Rex Attachments and Dissecting Tools
Medtronic Powered Surgical Solutio510(k) NO: K202552(Traditional)
ATTN: Jainam Shah PHONE NO : 817 7886686
4620 North Beach Street SE DECISION MADE: 02-NOV-20
Fort Worth TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ellusa Bipolar Wands
Ellusa, LLC 510(k) NO: K202558(Traditional)
ATTN: Suzanne Lucas PHONE NO : 516 8660001
2473 Grand Avenue SE DECISION MADE: 02-NOV-20
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set
Ellusa, LLC 510(k) NO: K202562(Traditional)
ATTN: Suzanne Lucas PHONE NO : 516 8660001
2473 Grand Avenue SE DECISION MADE: 02-NOV-20
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
Intuitive Surgical, Inc. 510(k) NO: K202571(Traditional)
ATTN: Elaine Lee PHONE NO : 408 5238887
1266 Kifer Road SE DECISION MADE: 12-NOV-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex TightRope II
Arthrex Inc. 510(k) NO: K202581(Traditional)
ATTN: Kelsey N. Roberts PHONE NO : 1 239 6435553 72257
1370 Creekside Boulevard SE DECISION MADE: 04-NOV-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioShield biopsy valve EUS - Linear
Steris Corporation 510(k) NO: K202583(Traditional)
ATTN: Jacqueline Oliver PHONE NO : 440 3586289
5976 Heisley Rd SE DECISION MADE: 06-NOV-20
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC Lateral Interbody System
Alphatec Spine, Inc. 510(k) NO: K202587(Traditional)
ATTN: Sandy Gill PHONE NO : 760 4946633
5818 El Camino Real SE DECISION MADE: 06-NOV-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
Medartis AG 510(k) NO: K202589(Traditional)
ATTN: Andrea Kiefer-Schweizer PHONE NO : 041 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 06-NOV-20
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexCath Advance Steerable Sheath and Dilator
Medtronic CryoCath LP 510(k) NO: K202620(Traditional)
ATTN: Matthew Lobeck PHONE NO : 763 5149515
8200 Coral Sea Street NE, MVS 46 SE DECISION MADE: 13-NOV-20
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-Span Plate System
Zavation Medical Products LLC 510(k) NO: K202624(Traditional)
ATTN: Frankie Cummins PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 04-NOV-20
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clio Prime and Clio Pedo
Sota Precision Optics, Inc. dba SO510(k) NO: K202664(Traditional)
ATTN: Bumsuk Kim PHONE NO : 714 5326100
1073 North Batavia Street, Suite BSE DECISION MADE: 06-NOV-20
Orange CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Triple Safety Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K202682(Special)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 24-NOV-20
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueView 100 Pro
CompAI Healthcare (Shenzhen) Co.,l510(k) NO: K202713(Traditional)
ATTN: Wang Yan PHONE NO : 86 18 051597307
8B, Huangting Building, No.355, FuSE DECISION MADE: 18-NOV-20
Shenzhen CN 518026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nd: YAG Laser Therapy Systems HM-YL900
Shangdong Huamei Technology Co., L510(k) NO: K202758(Traditional)
ATTN: Xu QingHua PHONE NO : 86 536 2110001
No. 588, Changning Street, High-teSE DECISION MADE: 16-NOV-20
WeiFang CN 261205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Circular Fixation with Balanced Cable Transport
Smith & Nephew, Inc. 510(k) NO: K202762(Traditional)
ATTN: Crystal Higgenbottom-ShaffePHONE NO : 901 8322616
7135 Goodlett Farm Parkway SE DECISION MADE: 16-NOV-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ortho Solutions Plating System
Ortho Solutions UK Ltd 510(k) NO: K202764(Traditional)
ATTN: Andy Leither PHONE NO : 44 1621 843599
West Station Business Park, SpitalSE DECISION MADE: 20-NOV-20
Maldon GB CMF 6FF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VeriFixx™ Small Bone Implant
Armis Biopharma, Inc. 510(k) NO: K202777(Traditional)
ATTN: Franklin Okumu PHONE NO : 908 6354172
2950 East Harmony Road, Suite 252 SE DECISION MADE: 17-NOV-20
Fort Collins CO 80528 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pacific Plus PTA Catheter
Medtronic Vascular,Inc(formerly d.510(k) NO: K202800(Traditional)
ATTN: Rupali Gupta PHONE NO : 763 3987000
3033 Campus Drive SE DECISION MADE: 18-NOV-20
Maple Grove MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optimized Positioning System (OPS) Insight
Corin USA 510(k) NO: K202805(Traditional)
ATTN: Lucinda Gerber PHONE NO : 1 813 9774469
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 20-NOV-20
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
Penumbra, Inc. 510(k) NO: K202821(Traditional)
ATTN: Michaela Mahl PHONE NO : 510 7483288
One Penumbra Place SE DECISION MADE: 18-NOV-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spo2 Sensor
JKH USA, LLC 510(k) NO: K202851(Traditional)
ATTN: Bill Quanqin Dai PHONE NO : 909 9299896
20505 Valley Blvd. Suite 108 SE DECISION MADE: 27-NOV-20
Walnut CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile bone screw (PEEK ACL screw)
Osteonic Co., Ltd. 510(k) NO: K202883(Traditional)
ATTN: Sungmoo Hwang PHONE NO : 82 2 69028426
38 Digital-ro 29-gil SE DECISION MADE: 25-NOV-20
Guro-gu KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Confirm Rx Insertable Cardiac Monitor
Abbott (St. Jude Medical) 510(k) NO: K202888(Traditional)
ATTN: Laura Sparks PHONE NO : 818 4932364
15900 Valley View Ct. SE DECISION MADE: 23-NOV-20
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Trocar
Wuxi Shukang Medical Appliance Co.510(k) NO: K202931(Traditional)
ATTN: Xiaoqing Yuan PHONE NO : 0086 510 87881818
No.83, Haitang West Road, Zhakou, SE DECISION MADE: 17-NOV-20
Yixing CN 214216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptoMonitor 3
Opsens Inc. 510(k) NO: K202943(Traditional)
ATTN: Marc Chaunet PHONE NO : 418 7810333 3408
750 boulevard Du Parc TechnologiquSE DECISION MADE: 24-NOV-20
Quebec CA G1P 4S3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PolyLock Plating System
Fusion Orthopedics, LLC 510(k) NO: K202959(Traditional)
ATTN: Eli Jacobson PHONE NO : 800 4036876
4135 S. Power Rd., Suite 110 SE DECISION MADE: 24-NOV-20
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft
New Deantronics Taiwan Ltd 510(k) NO: K202962(Traditional)
ATTN: Jane Liu PHONE NO : 886 2 22681726
12F., No.51, Sec.4, Zhongyang Rd.,SE DECISION MADE: 20-NOV-20
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA Architect
GE Healthcare (GE Medical Systems,510(k) NO: K202966(Traditional)
ATTN: Andrew Menden PHONE NO : 262 3085719
3200 N Grandview Blvd. SE DECISION MADE: 13-NOV-20
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anterior Cervical Plate System
Nutech Spine and Biologics 510(k) NO: K202972(Traditional)
ATTN: Grant Horton PHONE NO : 205 3297285
600 Luckie Drive, Suite 424 SE DECISION MADE: 24-NOV-20
Birmingham AL 35223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser Therapy Device
Shenzhen Leaflife Technology Co., 510(k) NO: K202980(Traditional)
ATTN: Cheng Qiang PHONE NO : 086 017 875910506
Bldg. C, JMD Industrial Park, No.3SE DECISION MADE: 19-NOV-20
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems Inc. 510(k) NO: K203008(Traditional)
ATTN: Nikita Basabdra PHONE NO : 651 2598206
1225 Old Highway 8 NW SE DECISION MADE: 19-NOV-20
Saint Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monster Screw System
Paragon 28, Inc. 510(k) NO: K203011(Special)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 13-NOV-20
Englewood CA 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
PENTAX of America, Inc. 510(k) NO: K203024(Traditional)
ATTN: Gurvinder Singh Nanda PHONE NO : 650 3168601
303 Convention Way, Suite 1 SE DECISION MADE: 24-NOV-20
Redwood, CA CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOBO Vascular Occlusion System (model LOBO-5)
Okami Medical 510(k) NO: K203025(Special)
ATTN: Jill Delsman PHONE NO : 949 3706314
8 Argonut Suite 100 SE DECISION MADE: 05-NOV-20
Aliso Viejo CA 92656 510(k) STATEMENT
DEVICE: IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
Galil Medical Inc. 510(k) NO: K203032(Special)
ATTN: Amy McKinney PHONE NO : 651 4020008
4634 Round Lake Rd W SE DECISION MADE: 02-NOV-20
Arden Hills MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSolution One Total Knee Application
THINK Surgical, Inc. 510(k) NO: K203040(Special)
ATTN: Meliha Mulalic PHONE NO : 510 2492337
47201 Lakeview Blvd SE DECISION MADE: 13-NOV-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical 070 Access System
Route 92 Medical, Inc. 510(k) NO: K203043(Special)
ATTN: Kathy Tansey PHONE NO : 650 5811179
155 Bovet Road, Suite 100 SE DECISION MADE: 11-NOV-20
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus™ Spinal Fixation System
Alphatec Spine, Inc. 510(k) NO: K203056(Traditional)
ATTN: Cynthia Dorne PHONE NO : 760 4946740
5818 E1 Camino Real SE DECISION MADE: 23-NOV-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)
STERIS Corporation 510(k) NO: K203061(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 06-NOV-20
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mecta-C Stand Alone Extension
Medacta International SA 510(k) NO: K203076(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 06-NOV-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
LSI Solutions 510(k) NO: K203081(Special)
ATTN: Christopher B Miller PHONE NO : 585 8696665
7796 Victor-Mendon Rd. SE DECISION MADE: 24-NOV-20
Victor NY 14564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insight Infrared Video Goggles
Vestibular First 510(k) NO: K203082(Third Party - Traditional)
ATTN: Helena Esmonde PHONE NO : 215 6678990
9 Mather Ave SE DECISION MADE: 12-NOV-20
Broomall PA 19008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NOVA Patient Warming System
Encompass Group, LLC 510(k) NO: K203085(Third Party - Traditional)
ATTN: Eric Howard PHONE NO : 800 2844540
615 Macon St SE DECISION MADE: 12-NOV-20
McDonough GA 30253 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Arthrex Eclipse Titanium Humeral Head
Arthrex Inc. 510(k) NO: K203100(Special)
ATTN: David L Rogers PHONE NO : 239 6435553
1370 Creekside Boulevard SE DECISION MADE: 20-NOV-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nio Fusion 12MP (MDNC-12130)
Barco NV 510(k) NO: K203106(Special)
ATTN: Julie Vandecandelaere PHONE NO : 32 56 262319
President Kennedypark 35 SE DECISION MADE: 10-NOV-20
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iFuse Implant System - iFuse Navigation
SI-BONE, Inc. 510(k) NO: K203110(Special)
ATTN: Nancy Kaiser PHONE NO : 408 4315858
471 El Camino Real, Suite 101 SE DECISION MADE: 09-NOV-20
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
LSI Solutions, Inc. 510(k) NO: K203120(Special)
ATTN: Christopher B Miller PHONE NO : 585 8696665
7796 Victor-Mendon Road SE DECISION MADE: 24-NOV-20
Victor NY 14589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
Olympus Medical Systems Corp. 510(k) NO: K203128(Special)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-machi SE DECISION MADE: 09-NOV-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIREBIRD SI Fusion System
Orthofix Inc. 510(k) NO: K203138(Special)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 18-NOV-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. MINI Posterior Cervical Screws System
Medacta International SA 510(k) NO: K203149(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 16-NOV-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KASILOF Cervical Plate System
Kahtnu Surgical, Inc 510(k) NO: K203154(Special)
ATTN: Craig Wilcox PHONE NO : 907 2023111
170 E. Corral Ave. Suite 1 SE DECISION MADE: 05-NOV-20
Soldotna AK 99669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DTX Studio Clinic
Nobel Biocare AB 510(k) NO: K203156(Traditional)
ATTN: Wim Vrydag PHONE NO : 41 79 29403703
Vastra Hamngatan 1 SE DECISION MADE: 20-NOV-20
Goteborg SE SE-402 26 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics Inc. 510(k) NO: K203167(Special)
ATTN: Erin Combs PHONE NO : 574 3727211
700 Orthopaedic Drive SE DECISION MADE: 19-NOV-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Ascend
GE Healthcare Japan Corporation 510(k) NO: K203169(Special)
ATTN: Tomohiro Ito PHONE NO : 81 425 855383
7-127, 4-Chome, Asahigaoka, SE DECISION MADE: 20-NOV-20
Hino JP 191-8503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExacTrac Dynamic
Brainlab AG 510(k) NO: K203173(Special)
ATTN: Chiara Cunico PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 12-NOV-20
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fortress Introducer Sheath System
Contract Medical International Gmb510(k) NO: K203179(Special)
ATTN: Marketa Shanelova PHONE NO : 420 494 949586
Lauensteiner Strasse 37 SE DECISION MADE: 20-NOV-20
Dresden DE 01277 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HiRise
CurveBeam, LLC 510(k) NO: K203187(Third Party - Traditional)
ATTN: Ryan Conlon PHONE NO : 267 4838081
2800 Bronze Drive, Suite 110 SE DECISION MADE: 18-NOV-20
Hatfield PA 19044 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: The Multimodality Advanced Vessel Analysis
Philips Medical Systems Nederland 510(k) NO: K203216(Third Party - Traditional)
ATTN: Vered Nitzan PHONE NO : 972 549 797047
Veenpluis 4-6 SE DECISION MADE: 25-NOV-20
PC Best NL 5684 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Arthrex FiberTak Suture Anchor
Arthrex Inc. 510(k) NO: K203268(Special)
ATTN: Jessica L Singelais PHONE NO : 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 27-NOV-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBSWIN, VISTAEASY
Dürr Dental SE 510(k) NO: K203287(Special)
ATTN: Oliver Lange PHONE NO : 49 07142 705190
Höpfigheimer Str. 17 SE DECISION MADE: 18-NOV-20
Bietigheim-Bissingen DE 74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear X Pedicle Screw System
CarboFix Orthopedics Ltd. 510(k) NO: K203317(Special)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 25-NOV-20
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 210
TOTAL WITH STATEMENTS 14
