510(k) K941366 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Jun 6, 1995 |
| Received | Mar 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Secur-Fit ARC/HA Collar Stem
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision t Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.