K230120
- 510(k) number
- K230120
- Device name
- KeYi Total Knee System
- Applicant
- Beijing Keyi Medical Device Technology Co., Ltd. CN
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-04-19
- Date received
- 2023-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230120.pdf
Official FDA record: K230120
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.