510(k) K062997 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 8, 2006 |
| Received | Oct 2, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062997
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2012 | Biomet, Inc. Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN
Product Usage:
Intended for use in non-cemented primary and revision Terminated |
LZO | None listed |
| Mar 2, 2012 | Biomet, Inc. OSS AVL Poly Tibial Bushing Set
OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures. Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.