Clearance Summary
iFuse Implant System - iFuse Navigation received FDA 510(k) clearance under submission number K203110, sponsored by SI-BONE, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-11-09.
- Submission: K203110
- Applicant / Sponsor: SI-BONE, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2020-11-09
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.