Clearance Summary
ANAX 5.5 Spinal System received FDA 510(k) clearance under submission number K162189, sponsored by U&I 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 2016-08-30.
- Submission: K162189
- Applicant / Sponsor: U&I Corporation
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2016-08-30
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.