510(k) K213108

Humerus & Ulna System by Auxein Medical Private Limited — Product Code HRS

K213108 is an FDA 510(k) premarket notification submitted by Auxein Medical Private Limited for the device "Humerus & Ulna System". The FDA issued a decision of Substantially Equivalent on November 4, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Auxein Medical Private Limited has at least 10 other 510(k) clearances on record.