510(k) K182301 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PFC SIGMA Knee System
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 8, 2019 |
| Received | Aug 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182301
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.