510(k) K150974

aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium by Aap Implantate AG — Product Code HWC

K150974 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium". The FDA issued a decision of Substantially Equivalent on April 29, 2015. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Aap Implantate AG has at least 10 other 510(k) clearances on record.