Clearance Summary
NFIX II PEDICLE SCREW SYSTEM received FDA 510(k) clearance under submission number K061774, sponsored by N Spine, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-12-13.
- Submission: K061774
- Applicant / Sponsor: N Spine, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2006-12-13
Classification & Regulation
This clearance is catalogued under FDA product code NQP and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.