510(k) K240528 · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
b-ONE® Total Hip System
| Applicant | B-One Ortho, Corp., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Nov 15, 2024 |
| Received | Feb 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240528
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.