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510(k) Data Aggregation

    K Number
    K031493
    Device Name
    GROWTH GUIDANCE PLATE
    Manufacturer
    UNIVERSITY OF UTAH/SCHOOL OF MEDICINE
    Date Cleared
    2003-11-20

    (192 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSITY OF UTAH/SCHOOL OF MEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guided Growth Plate is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. 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 (humerus) *radial or ulnar deviation, flexion or extension deformities of the wrist (radius)
    Device Description
    The two hole plate features a contoured waist and low profile for pediatric usage. There is a center hole for accurate application of the plate over a temporary guide pin. This is to facilitate precise and reproducible placement of the implant relative to the adjacent growth plate that is localized radiographically.. The plate is available in two sizes (small / large) to accommodate the variations of bone size and geometry. It is transfixed to the bone using two parallel cannulated titanium screws. The Guided Growth Plate is made out of titanium which is (by design) flexible and compatible with both radiographic imaging and MRI.
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