510(k) K943774 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
OSTEONICS RESTORATION MONOLITHIC HIP STEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Mar 6, 1995 |
| Received | Aug 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943774
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.