K252725
- 510(k) number
- K252725
- Device name
- Stem Extension Line (U2 Total Knee SystemPSA Type)
- Applicant
- United Orthopedic Corporation TW
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2025-09-25
- Date received
- 2025-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252725.pdf
Official FDA record: K252725
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.