510(k) K191765 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OMNI TiN Coated Apex Knee System
| Applicant | Omni Life Science, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Sep 25, 2019 |
| Received | Jul 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191765
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.