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510(k) Data Aggregation

    K Number
    K012320
    Device Name
    POWERPRO BATTERY SYSTEM
    Manufacturer
    LINVATEC CORP.
    Date Cleared
    2001-10-19

    (88 days)

    Product Code
    HAB, FRG, GEY, HBC
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    HAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPro™ Battery System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include orthopedic procedures such as osteotomies, small and large bone trauma, orthopedic reconstruction, and total joint replacement, neurosurgical fusion and plating procedures, and medial sternotomy. The PowerPro Battery System also includes a sterilization case to enclose the rechargeable batteries during sterilization, and also to maintain sterility of the batteries until used.
    Device Description
    The PowerPro Battery System is a powered instrument system consisting of various pistol-grip handpieces, universal battery charger, rechargeable batteries and sterilization trays. The handpieces utilize various attachments, such as blades, burs, drills and routers.
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