510(k) K913812 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Nov 22, 1991 |
| Received | Aug 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913812
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.