510(k) K942263 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent for Some Indications, Jul 11, 1995 |
| Received | May 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. FEM PRC LT M/RT L SML
FEM PRC RT M/LT L SML
FEM PRC LT M/RT L SML+
FEM PRC RT M/LT L SML+
FEM PRC LT M/RT L REG
FEM PRC RT M/LT L REG
FEM PRC LT M/R Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.