Clearance Summary
iFuse Implant System- iFuse Navigation received FDA 510(k) clearance under submission number K172268, sponsored by SI-BONE, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-10-31.
- Submission: K172268
- Applicant / Sponsor: SI-BONE, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2017-10-31
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.