510(k) K193549 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
SIGMA High Performance (HP) Partial Knee System
| Applicant | Depuy Ireland UC, Ringaskiddy, IE |
| Decision | Substantially Equivalent, Apr 16, 2020 |
| Received | Dec 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193549
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.