510(k) K911585 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OMNIFIT II EPF HIP STEM SERIES
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Jul 1, 1991 |
| Received | Apr 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911585
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.