Clearance Summary
Auxein Brand Vertaux 5.5 mm Pedicle Screw System received FDA 510(k) clearance under submission number K201457, sponsored by Auxein Medical Private Limited/71164. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-04-06.
- Submission: K201457
- Applicant / Sponsor: Auxein Medical Private Limited/71164
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2021-04-06
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.