510(k) K182818

LOQTEQ VA Calcaneus Plate 3.5 by Aap Implantate AG — Product Code HRS

K182818 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "LOQTEQ VA Calcaneus Plate 3.5". The FDA issued a decision of Substantially Equivalent on August 1, 2019. 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.