Clearance Summary
U&I, OPTIMA, SPINAL SYSTEM received FDA 510(k) clearance under submission number K031585, sponsored by U&I Corp., America. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-06-27.
- Submission: K031585
- Applicant / Sponsor: U&I Corp., America
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2003-06-27
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.