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510(k) Data Aggregation

    K Number
    K974406
    Device Name
    ORTHOPLAN
    Manufacturer
    ORTHO-GRAPHICS, INC.
    Date Cleared
    1998-02-18

    (89 days)

    Product Code
    HWT
    Regulation Number
    888.4800
    Why did this record match?
    Product Code :

    HWT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries.
    Device Description
    Not Found
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    K Number
    K960685
    Device Name
    ORTHODOC PREOPERATIVE PLANNER MODEL 500
    Manufacturer
    INTEGRATED SURGICAL SYSTEMS, INC.
    Date Cleared
    1997-01-17

    (332 days)

    Product Code
    HWT
    Regulation Number
    888.4800
    Why did this record match?
    Product Code :

    HWT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import computed tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.
    Device Description
    This software is designed to run on a PentiumR-based personal computer. The device is a software-only product and is not intended to operate any other medical device or act directly on a patient. The application stores scaled graphic images of femoral stem components and provides a means for surgeons to superimpose these patterns on a CT image of the patient's femur. The implant patterns can be moved over the femur images to select what in the surgeon's judgement is the best stem size, position, neck length, and head diameter to achieve the physician's surgical goal. The library of implant patterns, called surface model files, is developed from computer-aided-design (CAD) geometric data supplied by the implant's manufacturer. The implant surface model file used by ORTHODOC contains implant identification information as well as geometric data which defines the shape and dimensions of the implant surface.
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