K243656
- 510(k) number
- K243656
- Device name
- U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella
- Applicant
- United Orthopedic Corporation TW
- Product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
- Decision date
- 2025-07-31
- Date received
- 2024-11-26
- 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: K243656.pdf
Official FDA record: K243656
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.