KeriFlex® MCP And PIP Finger Joint Prostheses
Prosthesis, Finger, Constrained, Polymer
Keri Medical SA
The following data is part of a premarket notification filed by Keri Medical Sa with the FDA for Keriflex® Mcp And Pip Finger Joint Prostheses.
Pre-market Notification Details
| Device ID | K211385 |
| 510k Number | K211385 |
| Device Name: | KeriFlex® MCP And PIP Finger Joint Prostheses |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | Keri Medical SA Route Des Acacias, 45a Geneva, CH CH-1227 |
| Contact | Bernard Prandi |
| Correspondent | Bernard Prandi Keri Medical SA Route Des Acacias, 45a Geneva, CH CH-1227 |
| Product Code | KYJ |
| CFR Regulation Number | 888.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2022-07-27 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640181160693 | K211385 | 000 |
| 07640181160594 | K211385 | 000 |
| 07640181160600 | K211385 | 000 |
| 07640181160617 | K211385 | 000 |
| 07640181160624 | K211385 | 000 |
| 07640181160631 | K211385 | 000 |
| 07640181160648 | K211385 | 000 |
| 07640181160655 | K211385 | 000 |
| 07640181160662 | K211385 | 000 |
| 07640181160679 | K211385 | 000 |
| 07640181160686 | K211385 | 000 |
| 07640181160587 | K211385 | 000 |
Trademark Results [KeriFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KERIFLEX 97532902 not registered Live/Pending |
KERI MEDICAL SA 2022-08-03 |
 KERIFLEX 88361038 not registered Live/Pending |
Wellin Inc. 2019-03-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.