Clearance Summary
NGARDE SYSTEM received FDA 510(k) clearance under submission number K072685, sponsored by N Spine, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-10-19.
- Submission: K072685
- Applicant / Sponsor: N Spine, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2007-10-19
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.