510(k) K180612 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
| Applicant | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jun 7, 2018 |
| Received | Mar 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180612
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.