510(k) K113271 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
| Applicant | Biomet Manufacturing, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 18, 2012 |
| Received | Nov 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113271
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.