510(k) K081023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EVOLIS TOTAL KNEE SYSTEM
| Applicant | Medacta International S.A., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 22, 2008 |
| Received | Apr 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081023
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2009 | Medacta Usa Inc Evolis-Femoral Sizer Posterior Reference
The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The f Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.