510(k) K936045

ACE UNILATERAL FIXATOR II by Ace Orthopedic Manufacturing Co. — Product Code JEC

K936045 is an FDA 510(k) premarket notification submitted by Ace Orthopedic Manufacturing Co. for the device "ACE UNILATERAL FIXATOR II". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Ace Orthopedic Manufacturing Co. has at least 10 other 510(k) clearances on record.