510(k) K182705 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
| Applicant | B-One Ortho, Corp., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Feb 14, 2019 |
| Received | Sep 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182705
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.