510(k) K945115 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 2, 1995 |
| Received | Oct 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures. Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.