510(k) K153057 · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
FitRite Total Hip Arthroplasty System
| Applicant | Excera Orthopedics, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Jun 23, 2016 |
| Received | Oct 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153057
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.