LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100404
    Device Name
    ASCENDX VCF REDUCTION SYSTEM
    Manufacturer
    AOI MEDICAL, INC.
    Date Cleared
    2012-12-14

    (1032 days)

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

    AOI MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ascendx™M VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.
    Device Description
    The Ascendx™ VCF Repair System consists of the Ascendx™ Acu-Cut Cutting Instrument, AscendxTM RDX Repair Device, and AscendxTM Inflation Syringe. The Ascendx™ System is packaged with a previously cleared bone cement (Ascendx™ Cement, manufactured by TECRES S.p.A, K042415), as well as several class I tools, including manual orthopedic surgical instruments and cement mixing and dispensing tools.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1