510(k) K041950 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
APEX K2 HIP SYSTEM
| Applicant | Apex Surgical, LLC, Lakeville MA, US |
| Decision | Substantially Equivalent, Dec 21, 2004 |
| Received | Jul 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041950
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2021 | OmniLife Science OMNI K2 Hip Stem, Manufacturer's Product Code 130006
The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for unceme Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.