510(k) K180930 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EMPOWR VVC TIBIAL INSERT
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Jul 9, 2018 |
| Received | Apr 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180930
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2023 | Encore Medical, LP EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708;
EMPOWR VVC KNE Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.