510(k) K161696

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 by Aap Implantate AG — Product Code HRS

K161696 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5". The FDA issued a decision of Substantially Equivalent on November 23, 2016. 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.