510(k) K251525

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System by Si-Technology, LLC — Product Code OUR

K251525 is an FDA 510(k) premarket notification submitted by Si-Technology, LLC for the device "SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System". The FDA issued a decision of Substantially Equivalent on June 6, 2025. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Si-Technology, LLC has at least 2 other 510(k) clearances on record.