510(k) K242045 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Initia T3 Acetabular Hemispherical Shell System
| Applicant | Kyocera Medical Technologies, Inc., Redlands CA, US |
| Decision | Substantially Equivalent, Apr 10, 2025 |
| Received | Jul 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242045
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.