510(k) K250894

Eminent Spine Posterior SI System by Eminent Spine — Product Code OUR

K250894 is an FDA 510(k) premarket notification submitted by Eminent Spine for the device "Eminent Spine Posterior SI System". The FDA issued a decision of Substantially Equivalent on October 7, 2025. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Eminent Spine has at least 10 other 510(k) clearances on record.