510(k) K173380 · 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, Aug 30, 2018 |
| Received | Oct 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173380
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.