
Hand Biomechanics Lab, Inc.
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WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS is an FDA 510(k)-cleared medical device (K033112) manufactured by Hand Biomechanics Lab, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2003. Regulation: 8.