510(k) K243995

Arthrex Humeral Plating System and Cerclage Button by Arthrex, Inc. — Product Code HRS

K243995 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Humeral Plating System and Cerclage Button". The FDA issued a decision of Substantially Equivalent on March 26, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.