510(k) K813554

ACE/KYLE CAPTURED HIP SCREW by Ace Orthopedic Manufacturing Co. — Product Code KTT

K813554 is an FDA 510(k) premarket notification submitted by Ace Orthopedic Manufacturing Co. for the device "ACE/KYLE CAPTURED HIP SCREW". The FDA issued a decision of Substantially Equivalent on January 12, 1982. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Ace Orthopedic Manufacturing Co. has at least 10 other 510(k) clearances on record.