510(k) K911197 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM
| Applicant | Orthomet, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 23, 1991 |
| Received | Mar 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911197
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.