TOUCH® CMC 1 Prosthesis
FDA premarket approval P240020/S003 · decided 2025-12-17
Approval details
- PMA number
- P240020
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TOUCH® CMC 1 Prosthesis
- Generic name
- Prosthesis, finger, semi-constrained, metal/polymer
- Applicant
- Keri Medical SA
- Date received
- 2025-11-17
- Decision date
- 2025-12-17
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- SFA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- 1228 Plan-Les-Ouates
- Statement
- Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240020
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| KeriFlex® MCP and PIP Finger Joint Prostheses (K211385) | Keri Medical SA | 2022-07-27 |