510(k) K233508

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

K233508 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 January 26, 2024. 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.