510(k) K141949

CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM by Aap Implantate AG — Product Code HWC

K141949 is an FDA 510(k) premarket notification submitted by Aap Implantate AG for the device "CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM". The FDA issued a decision of Substantially Equivalent on September 12, 2014. 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.