510(k) K982032 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Jul 9, 1998 |
| Received | Jun 10, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Omnifit HA Hip 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 total hip a Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.