510(k) K033112

WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS by Hand Biomechanics Lab, Inc. — Product Code KTT

K033112 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS". The FDA issued a decision of Substantially Equivalent on November 5, 2003. 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 Biomechanics Lab, Inc. has at least 8 other 510(k) clearances on record.