Clearance Summary
UNITED U2 BIPOLAR IMPLANT received FDA 510(k) clearance under submission number K101670, sponsored by United Orthopedic Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-10-08.
- Submission: K101670
- Applicant / Sponsor: United Orthopedic Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 2010-10-08
Classification & Regulation
This clearance is catalogued under FDA product code KWY and 21 CFR 888.3390, within the Orthopedic review panel as a Class II device.