510(k) K862837 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Dec 22, 1986 |
| Received | Jul 25, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862837
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.