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    K Number
    K113452
    Device Name
    ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
    Manufacturer
    ASCENDX SPINE, INC.
    Date Cleared
    2012-02-17

    (88 days)

    Product Code
    NDNKIH
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASCENDX SPINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.
    Device Description
    The Acu-Cut Vertebral Augmentation System consists of: - the Acu-Cut Cutting Instrument . - . 2 Cannulas - 1 Tri-Point Tip Trocar . - 1 Bevel Tip Trocar ● - 1 Hand Drill ● - · 5 Cement Delivery Tubes with Plungers - · A previously FDA cleared bone cement.
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