510(k) K150017

SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System by Spinefrontier, Inc. — Product Code OUR

K150017 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System". The FDA issued a decision of Substantially Equivalent on April 24, 2015. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Spinefrontier, Inc. has at least 10 other 510(k) clearances on record.