510(k) K926047

ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW by Ace Orthopedic Manufacturing Co. — Product Code HWC

K926047 is an FDA 510(k) premarket notification submitted by Ace Orthopedic Manufacturing Co. for the device "ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Ace Orthopedic Manufacturing Co. has at least 10 other 510(k) clearances on record.