510(k) K222431 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
b-ONER MOBIO Total Knee System
| Applicant | B-One Ortho, Corp., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Oct 6, 2022 |
| Received | Aug 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222431
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.