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510(k) Data Aggregation

    K Number
    K955761
    Device Name
    TIBIA ORTHONAIL
    Manufacturer
    ORTHOLOGIC CORP.
    Date Cleared
    1996-03-13

    (86 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOLOGIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    indicated for stabilizing tibral fractures.
    Device Description
    The Tibia OrthoNail is a solid cylinder. The Tibia OrthoNail is available in diameters, 9 - 14 mm and in lengths of 200 - 425 mm. The device is designed to accept transfixing screws. End caps are provided. For use during insertion an Impacting Anvil is provided. An Alignment Tower is provided to ensure proper alignment of transfixation screw holes. The Anvil has an internal proximal thread for attachment of a slaphammer that is used for insertion or distraction.
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