Clearance Summary
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws received FDA 510(k) clearance under submission number K141680, sponsored by Auxein Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-06-30.
- Submission: K141680
- Applicant / Sponsor: Auxein Medical
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2015-06-30
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.