510(k) K912735 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
GENESIS UNICOMPARTMENTAL KNEE SYSTEM
| Applicant | Smith & Nephew Richards, Inc., Memphis TN, US |
| Decision | Substantially Equivalent for Some Indications, Dec 27, 1991 |
| Received | Jun 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2004 | Smith & Nephew Inc Genesis Uni Articular Inserts Terminated |
HSX | None listed |
| Dec 14, 2004 | Smith & Nephew Inc Tibial Base Plates Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.