K232114
- 510(k) number
- K232114
- Device name
- TRIBRID® Unicompartmental Knee System
- Applicant
- Kyocera Medical Technologies, Inc. CA · US
- Product code
- HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cem
- Decision date
- 2024-04-04
- Date received
- 2023-07-14
- 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: K232114.pdf
Official FDA record: K232114
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.