510(k) K142707

AIS Odontoid Fracture Fixation System by Aesculap Implant System, Inc. — Product Code HWC

K142707 is an FDA 510(k) premarket notification submitted by Aesculap Implant System, Inc. for the device "AIS Odontoid Fracture Fixation System". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Aesculap Implant System, Inc. has at least 10 other 510(k) clearances on record.