510(k) K181866

MotoCLIP/HiMAX Step Staple Implant System by Crossroads Extremity Systems, LLC — Product Code JDR

K181866 is an FDA 510(k) premarket notification submitted by Crossroads Extremity Systems, LLC for the device "MotoCLIP/HiMAX Step Staple Implant System". The FDA issued a decision of Substantially Equivalent on August 9, 2018. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Crossroads Extremity Systems, LLC has at least 10 other 510(k) clearances on record.