510(k) K210191 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Identity Imprint Knee Replacement System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, May 6, 2021 |
| Received | Jan 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2024 | Conformis, Inc. Identity Imprint PS Tibial Tray Size 4: Lot 540287 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.