510(k) K132787

LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE by Aap Implantate AG — Product Code HRS

K132787 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE". The FDA issued a decision of Substantially Equivalent on December 24, 2013. 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.