K243295
- 510(k) number
- K243295
- Device name
- Initia Knee System
- Applicant
- Kyocera Medical Technologies, Inc. CA · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2025-01-13
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243295.pdf
Official FDA record: K243295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.