Clearance Summary
U2 Total Knee System, PSA Tibial Insert received FDA 510(k) clearance under submission number K161360, sponsored by United Orthopedic Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-02-01.
- Submission: K161360
- Applicant / Sponsor: United Orthopedic Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2017-02-01
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.