510(k) K954800 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
| Applicant | Intermedics Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Apr 25, 1996 |
| Received | Sep 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954800
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2015 | Zimmer Gmbh CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degene Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.