510(k) K191325 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
EMPOWR Partial Knee
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Jul 16, 2019 |
| Received | May 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191325
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2020 | Encore Medical, LP EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. Open, Classified |
HSX | None listed |
| Jun 19, 2020 | Encore Medical, LP EMPOWR Partial Knee Peg Drill; Model: 800-06-008. Open, Classified |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.