K211385 is an FDA 510(k) clearance for the KeriFlex® MCP and PIP Finger Joint Prostheses. This device is classified as a Prosthesis, Finger, Constrained, Polymer (Class II - Special Controls, product code KYJ).
Submitted by Keri Medical SA (Geneva, CH). The FDA issued a Cleared decision on July 27, 2022, 449 days after receiving the submission on May 4, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3230.
| 510(k) Number | K211385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2021 |
| Decision Date | July 27, 2022 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KYJ - Prosthesis, Finger, Constrained, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3230 |