510(k) K033363 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 16, 2004 |
| Received | Oct 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. ZUK PRC FEM SZB RMED/LLAT
ZUK PRC FEM SZC LMED/RLAT
ZUK PRC FEM SZC RMED/LLAT
NGU PRC FEM SZD LMED/RLAT
ZUK PRC FEM SZD RMED/LLAT
ZUK PRC FEM SZE LMED/RLAT
ZUK PRC FEM SZF RMED/LLAT
" These devices a Terminated |
HSX | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. ZIMMER UNI HIGH FLEX PRECOAT FEM
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
various sizes
These devices are indicated for patients with: - Painful and/or disabling knee Terminated |
HSX | None listed |
| Oct 25, 2013 | Zimmer, Inc. Zimmer Unicompartmental Knee Femoral Component.
Indicated for patients with painful and/or disabling knee joint. Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.