510(k) K920193 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
OMNIFLEX M-HA HIP STEM SERIES
| Applicant | Stryker Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Jun 8, 1992 |
| Received | Jan 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920193
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Omniflex-HA Hip Stem W/C Taper.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
KWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.