510(k) K230846 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Jul 17, 2023 |
| Received | Mar 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230846
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.