Clearance Summary
OPTIMA SPINAL SYSTEM received FDA 510(k) clearance under submission number K051971, sponsored by U&I Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-08-04.
- Submission: K051971
- Applicant / Sponsor: U&I Corp.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2005-08-04
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.