510(k) K250247

panaSIa SI Fusion System by Wenzel Spine, Inc. — Product Code OUR

K250247 is an FDA 510(k) premarket notification submitted by Wenzel Spine, Inc. for the device "panaSIa SI Fusion System". The FDA issued a decision of Substantially Equivalent on July 9, 2025. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Wenzel Spine, Inc. has at least 8 other 510(k) clearances on record.