Clearance Summary
United U2 femoral head, 22mm delta ceramic head received FDA 510(k) clearance under submission number K221675, sponsored by United Orthopedic Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-11-04.
- Submission: K221675
- Applicant / Sponsor: United Orthopedic Corporation
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2022-11-04
Classification & Regulation
This clearance is catalogued under FDA product code LPH and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.