510(k) K002324 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
| Applicant | Sulzermedica, Austin TX, US |
| Decision | Substantially Equivalent, Aug 24, 2000 |
| Received | Jul 31, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002324
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2012 | Zimmer Inc. 5100-03-707 -- MOST Option STEM DISTRACTOR
MATL: SS NONSTERILE QTY-1
Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components, implant connections a Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.