510(k) K100555 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
| Applicant | Omni Life Science, Inc., East Taunton MA, US |
| Decision | Substantially Equivalent, Mar 29, 2010 |
| Received | Mar 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
ApeX-LNK crosslinked Acetabular Insert, 10 deg hood;
Product Code : H5-54840 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.