Clearance Summary
iFuse Granite Onyx Implant System received FDA 510(k) clearance under submission number K262067, 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 2026-09-23.
- Submission: K262067
- Applicant / Sponsor: SI-BONE, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2026-09-23
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.