510(k) K974728 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
INTER-OP METASUL ACETABULAR SYSTEM
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 3, 1999 |
| Received | Dec 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974728
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2015 | Zimmer Gmbh Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease. Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.