510(k) K090845 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
APEX ARC HIP STEM
| Applicant | Omni Life Science, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Apr 7, 2010 |
| Received | Mar 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2015 | Omnilife Science Inc. Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA
Product Usage:
The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is Terminated |
LZO | None listed |
| Aug 15, 2014 | Omnilife Science Inc. Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.