510(k) K111193 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
APEX ARC HIP STEM
| Applicant | Omni Life Science, Inc., East Taunton MA, US |
| Decision | Substantially Equivalent, Jun 27, 2011 |
| Received | Apr 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111193
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.