510(k) K101976 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
| Applicant | Omni Life Science, Inc., East Taunton MA, US |
| Decision | Substantially Equivalent, Sep 14, 2010 |
| Received | Jul 13, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2018 | OMNIlife science Inc. OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836
Product Usage:
The Apex Hip System is intended for primary or revision total hip repla Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.