Clearance Summary
NFIX FUSION SYSTEM received FDA 510(k) clearance under submission number K053623, 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 2006-07-12.
- Submission: K053623
- Applicant / Sponsor: N-Spine, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2006-07-12
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.