510(k) K213389 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Nov 10, 2021 |
| Received | Oct 15, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213389
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.