510(k) K161703

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer by Aap Implantate AG — Product Code HRS

K161703 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer". The FDA issued a decision of Substantially Equivalent on November 4, 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.