510(k) K260761

APTUS Clavicle System 2.8 by Medartis AG — Product Code HRS

K260761 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "APTUS Clavicle System 2.8". The FDA issued a decision of Substantially Equivalent on June 5, 2026. 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.