510(k) K963028 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TIBIAL INSERT
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Oct 1, 1996 |
| Received | Aug 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963028
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.