510(k) K050124 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
POROUS COATED ACETABULAR COMPONENTS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 4, 2005 |
| Received | Jan 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2012 | Biomet, Inc. Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component.
Intended Use: The shell utilizes a modular polyethylene liner and a f Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.