510(k) K984442

AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 by Hand Biomechanics Lab, Inc. — Product Code JEC

K984442 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147". The FDA issued a decision of Substantially Equivalent on February 12, 1999. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Hand Biomechanics Lab, Inc. has at least 8 other 510(k) clearances on record.