510(k) K163332 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Apex Revision Knee System
| Applicant | Omnilife Science, Raynham MA, US |
| Decision | Substantially Equivalent, Apr 26, 2017 |
| Received | Nov 28, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163332
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.