510(k) K253094

iFuse Bedrock Granite Implant System by SI-BONE, Inc. — Product Code OUR

K253094 is an FDA 510(k) premarket notification submitted by SI-BONE, Inc. for the device "iFuse Bedrock Granite Implant System". The FDA issued a decision of Substantially Equivalent on October 9, 2025. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. SI-BONE, Inc. has at least 10 other 510(k) clearances on record.