4ca34d90-0f67-4c71-9082-4ba5bb9bf2c6NewPublished12022-12-162022-12-08In Commercial DistributionB770EL0PrimaryHIBCCStat-A-Dyne ElbowElbowElbow614335276LANTZ MEDICAL, INC.1Orthosis providing flexion and extension of elbowfalsetruefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse41053Elbow orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.falseActiveIQIOrthosis, Limb Bracefalsefalse