K242045
- 510(k) number
- K242045
- Device name
- Initia T3 Acetabular Hemispherical Shell System
- Applicant
- Kyocera Medical Technologies, Inc. CA · US
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2025-04-10
- Date received
- 2024-07-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242045.pdf
Official FDA record: K242045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.