510(k) K983128 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
| Applicant | Implex Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 3, 1998 |
| Received | Sep 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983128
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.