Clearance Summary
VELOFIXTM INTERBODY FUSION SYSTEM received FDA 510(k) clearance under submission number K132926, sponsored by U&I 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 2014-03-05.
- Submission: K132926
- Applicant / Sponsor: U&I Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2014-03-05
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.