K252303
- 510(k) number
- K252303
- Device name
- Stem Extension Line (USTAR II System)
- Applicant
- United Orthopedic Corporation TW
- Product code
- KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemente
- Decision date
- 2025-08-22
- Date received
- 2025-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252303.pdf
Official FDA record: K252303
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.