510(k) K944836 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Apr 10, 1995 |
| Received | Sep 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2003 | Stryker Howmedica Osteonics Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218. Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.