510(k) K254253

LOQTEQ® VA Proximal Humerus Plate 3.5 by Aap Implantate AG — Product Code HRS

K254253 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "LOQTEQ® VA Proximal Humerus Plate 3.5". The FDA issued a decision of Substantially Equivalent on March 24, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Aap Implantate AG has at least 10 other 510(k) clearances on record.