Clearance Summary
ACROSSPINE PEDICLE SCREW SYSTEM received FDA 510(k) clearance under submission number K141695, sponsored by Arthro-Dif. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-12-30.
- Submission: K141695
- Applicant / Sponsor: Arthro-Dif
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2014-12-30
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.