510(k) K951291 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS RESTORATION MONOLITHIC HIP STEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Aug 9, 1995 |
| Received | Mar 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951291
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.