K244039
- 510(k) number
- K244039
- Device name
- MedalOne Total Knee System
- Applicant
- Suzhou Microport Orthorecon Co., Ltd. CN
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2025-02-28
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K244039.pdf
Official FDA record: K244039
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.