510(k) K060072 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MONOBLOCK PRESS-FIT HIP STEM
| Applicant | Omni Life Science, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Aug 24, 2006 |
| Received | Jan 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2019 | OMNIlife science Inc. OMNI Hip System
Model, Catalogue, or Order Number(s): HC-00070
Intended for use as the femoral component of a primary or revision total hip replacement. Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.