510(k) K963109 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
HERITAGE HIP SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 9, 1997 |
| Received | Aug 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 70 consists of all product under product code: JDI and same usage:
Item no:
785701000 VERSYS HERITAGE FEM STEM
785701100 VERSYS HERITAGE FEM STEM
785701200 VERSYS HERITAGE FEM STEM
785701300 Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. 12/14 UNIPOLAR FEMORAL HE
VERSYS CEM LD/FX SZ 11X12
VERSYS CEM LD/FX SZ 12X12
VERSYS CEM LD/FX SZ 14X13
VERSYS CEM LD/FX SZ 16X14
VERSYS CEM LD/FX ST 18X15
VERSYS PRESS FIT LD/FX ST
VERSYS PRESS FIT L Terminated |
JDI | None listed |
| Nov 14, 2013 | Zimmer, Inc. VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems
VerSys Heritage Hip System Revision Femoral Stems.
Indicated for total hip arthroplasty. Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.