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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, bone, growth control, pediatric, epiphysiodesis
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused.
Product CodeOBT
Regulation Number 888.3030
Device Class 2

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