510(k) K140830 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EXPRT REVISION KNEE
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Jul 11, 2014 |
| Received | Apr 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2015 | Encore Medical, Lp Exprt Precision System: Revision Knee, Model Number 160-010-726/738
For use with the Exprt Knee System in total knee arthroplasty to replace the native patella. Terminated |
OIY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.