510(k) clearance
KeriFlex® MCP and PIP Finger Joint Prostheses
- 510(k) number
- K263582
- Applicant
- Keri Medical SA
- Decision date
- Oct 29, 2026
- Date received
- Sep 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- KYJ
- Device type
- Prosthesis, Finger, Constrained, Polymer
- Device class
- Class II
- Regulation
- 21 CFR 888.3230
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Plan-Les-Ouates, CH