510(k) K914565 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, May 15, 1992 |
| Received | Oct 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914565
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. TIBIAL BEARING INSERT SERIES P-S I ASSY
Intended for knee replacement
Product Number: 7291-0324 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.