510(k) K180446 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
b-ONE Total Knee System
| Applicant | B-One Ortho, Corp., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Feb 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180446
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.