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510(k) Data Aggregation

    K Number
    K062572
    Device Name
    CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
    Manufacturer
    Date Cleared
    2007-05-11

    (253 days)

    Product Code
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOM SCIENTIFIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.
    Device Description
    The device contains a reconstruction plate and screws of TiAl6V4 titanium alloy, and a stainless steel bone transport unit, activation screw and flexible cable.
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