2024 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| Aeon ACKit Platelet And Plasma Separator For Bone Graft Handling |
The Aeon ACKit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. | BK231016/0 | Aeon Biotherapeutics Corp. 12F., No. 58, Ruihu St. Taipei City, Neihu District Taiwan, 11494 |
02/16/2024 |