510(k) K223819

SI-Cure Sacroiliac Joint Fusion System by Alevio, LLC — Product Code OUR

K223819 is an FDA 510(k) premarket notification submitted by Alevio, LLC for the device "SI-Cure Sacroiliac Joint Fusion System". The FDA issued a decision of Substantially Equivalent on January 18, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Alevio, LLC has at least 1 other 510(k) clearance on record.