510(k) K003758 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
ALLOFIT ACETABULAR SYSTEM
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Mar 7, 2001 |
| Received | Dec 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003758
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.