510(k) K946234 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 10, 1995 |
| Received | Dec 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946234
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.