510(k) K101336 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
E1 AVANTAGE HEAD
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 14, 2011 |
| Received | May 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101336
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2013 | Biomet, Inc. Active Articulation E1.
Intended for use with either primary or revision hip arthroplasty. Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.