510(k) K980486 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
| Applicant | Implex Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 14, 1998 |
| Received | Feb 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. REV. SHELL LINER 0D 28X48 00700504828
REV. SHELL LINER 10D 28X50 00701005028
REV. SHELL LINER 10D 28X52 00701005228
REV. SHELL LINER 10D 28X54 00701005428
REV. SHELL LINER 10D 28X56 00701005628 Terminated |
JDI | None listed |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM
00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM
00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM
00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM
00720505228 ACETAB.CUPW/SH,0 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.