510(k) K042458

A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM by A.M. Surgical, Inc. — Product Code LXT

K042458 is an FDA 510(k) premarket notification submitted by A.M. Surgical, Inc. for the device "A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 7, 2004. The device falls under product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite), a Class II device regulated under 21 CFR 888.3030. A.M. Surgical, Inc. has at least 5 other 510(k) clearances on record.