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510(k) Data Aggregation

    K Number
    K042591
    Device Name
    SMARTMIX PRE-FILLED MIXING SYSTEM
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2004-10-22

    (29 days)

    Product Code
    KIH, JDZ, LOD, MBB
    Regulation Number
    888.4200
    Why did this record match?
    Product Code :

    KIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SmartSet MV Endurance Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty. SmartSet GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
    Device Description
    SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid. The device is for single use only and reduces exposure to monomer fumcs and cement porosity during preparation and avoids handling of bone cement during cement delivery. The device is available in a single 60g or 100g unit. Each unit pack consists of the following: . A syringe barrel assembly pre-packed with bone cement powder. . A monomer cartridge pre-loaded with two ampoules of bone cement liquid. = Accessories consisting of a disposable mixing stand, a vacuum hose with filter attached, a vacuum tube adaptor and a central mixing rod. SmartMix Bowl is a vacuum mixing system pre-packed with bone cement powder and liguid. The device is for single us only and reduces exposure to monomer fumes and cement porosity during preparation. The device is available in single 80g units. Each unit pack consists of the following: . A bowl base pre-packed with bone cement powder. T A monomer cartridge pre-loaded with two ampoules of bone cement liquid. . Accessories consisting of a bowl lid with vacuum hose and filter attached, a vacuum tube adaptor and a spatula.
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