510(k) K232211

REUNION Sacroiliac Joint Fusion System by Astura Medical — Product Code OUR

K232211 is an FDA 510(k) premarket notification submitted by Astura Medical for the device "REUNION Sacroiliac Joint Fusion System". The FDA issued a decision of Substantially Equivalent on October 24, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Astura Medical has at least 10 other 510(k) clearances on record.