Clearance Summary
iFuse Bedrock Granite Implant System received FDA 510(k) clearance under submission number K253094, sponsored by SI-BONE, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-10-09.
- Submission: K253094
- Applicant / Sponsor: SI-BONE, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2025-10-09
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.