510(k) K112779 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
| Applicant | Omnlife Science, East Taunton MA, US |
| Decision | Substantially Equivalent, Dec 2, 2011 |
| Received | Sep 26, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2015 | Omnilife Science Inc. APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356.
Product Usage:
The Apex Interface Acetabular System is intended for use in combination with the Apex Mo Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.