510(k) K191084 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
The Optimotion Blue Total Knee System
| Applicant | Optimotion Implants, LLC, Winter Park FL, US |
| Decision | Substantially Equivalent, Apr 7, 2020 |
| Received | Apr 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191084
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.