510(k) K950312 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
ALPHA SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent for Some Indications, May 17, 1995 |
| Received | Jan 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 66 consists of all product under product code: JDI and same usage:
Item no:
785001100 VERSYS ADVOCATE CEMENTED
785001200 VERSYS ADVOCATE CEMENTED
785001220 VERSYS ADVOCATE CEMENTED
785001300 Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 69 consists of all product under product code: JDI and same usage:
Item no:
785301701 VERSYS CEMENTED FEM STEM
785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF
785301601 VERSYS CEMENTED FEM 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.