510(k) K100197 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Feb 19, 2010 |
| Received | Jan 22, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100197
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.