510(k) K253357 · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
b-ONE® Bipolar Head
| Applicant | B-One Ortho, Corp., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Apr 13, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253357
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.