510(k) K960278 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 25, 1996 |
| Received | Jan 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 11 consists of all product under product code JDI
, and same usage:
Item no:
902602500 6 DEGREE COCR FEM HEAD 26
902602600 6 DEGREE COCR FEM HEAD 26
902602700 6 DEGREE COCR FEM HEAD 26
902602 Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 64 consists of all product under product code: JDI and same usage:
Item no:
902605101 UNIPOLAR ENDO FEM HEAD 51MM
For use in hemi hip arthroplasty Terminated |
JDI | None listed |
| Aug 26, 2014 | Zimmer, Inc. Endo & Unipolar Femoral Heads:
ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, E Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.