510(k) K181067

AlignX Ankle Fusion System by Extremity Medical, LLC — Product Code HRS

K181067 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "AlignX Ankle Fusion System". The FDA issued a decision of Substantially Equivalent on May 23, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.