510(k) K242079

Arthrex Elbow Fracture Plating System by Arthrex, Inc. — Product Code HRS

K242079 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Elbow Fracture Plating System". The FDA issued a decision of Substantially Equivalent on November 14, 2024. 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.