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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?
    Applicant Name (Manufacturer) :

    ORTHO-GRAPHICS, INC.

    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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