510(k) K140607

AAP LOQTEC(R) OLECRANON PLATE by Aap Implantate AG — Product Code HRS

K140607 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "AAP LOQTEC(R) OLECRANON PLATE". The FDA issued a decision of Substantially Equivalent on May 8, 2014. 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.