510(k) K862632 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 25, 1987 |
| Received | Jul 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2009 | Zimmer Inc. Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01. Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.