Clearance Summary
iFUSE Implant System received FDA 510(k) clearance under submission number K160652, sponsored by SI-BONE, 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 2016-06-03.
- Submission: K160652
- Applicant / Sponsor: SI-BONE, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2016-06-03
Classification & Regulation
This clearance is catalogued under FDA product code OUR and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.