510(k) K071464

INION HEXALON BIODEGRADABLE ACL/PCL SCREW by Inion OY — Product Code HWC

K071464 is an FDA 510(k) premarket notification submitted by Inion OY for the device "INION HEXALON BIODEGRADABLE ACL/PCL SCREW". The FDA issued a decision of Substantially Equivalent on August 3, 2007. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Inion OY has at least 10 other 510(k) clearances on record.