510(k) K243610

APTUS Hand System; APTUS Elbow Dorsal Olecranon by Medartis AG — Product Code HRS

K243610 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "APTUS Hand System; APTUS Elbow Dorsal Olecranon". The FDA issued a decision of Substantially Equivalent on March 7, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Medartis AG has at least 10 other 510(k) clearances on record.