510(k) K964509 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
| Applicant | Implex Corp., Rockville MD, US |
| Decision | Substantially Equivalent, Jun 19, 1997 |
| Received | Nov 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964509
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.