510(k) K963255 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
| Applicant | Smith & Nephew, Inc., Orthopaedic Div., Memphis TN, US |
| Decision | Substantially Equivalent for Some Indications, Jan 2, 1997 |
| Received | Aug 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963255
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.