510(k) K041081

FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES by Hand Innovations, Inc. — Product Code KTT

K041081 is an FDA 510(k) premarket notification submitted by Hand Innovations, Inc. for the device "FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES". The FDA issued a decision of Substantially Equivalent on July 1, 2004. 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. Hand Innovations, Inc. has at least 10 other 510(k) clearances on record.