510(k) K935523 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NATURAL-KNEE(R)/APOLLO(TM) KNEE
| Applicant | Intermedics Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent, Jun 6, 1995 |
| Received | Nov 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935523
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee/Apollo" Knee:
M/B PAT SZ0 NATURAL-KNEE
M/B PAT SZ1 NATURAL-KNEE
M/B PAT SZ2 NATURAL-KNEE Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.