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510(k) Data Aggregation

    K Number
    K162154
    Device Name
    Pantheon Medical Balanced Plating System
    Manufacturer
    Date Cleared
    2017-04-24

    (265 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANTHEON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pantheon Medical Balanced Plating System is intended for fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities. This system is not intended for spinal use.
    Device Description
    The Pantheon Medical Balanced Plating System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and non-locking screws which mate into the plates, as well as a 4.0mm compression screw that is utilized with the Lapidus plate. Various instruments are also included to assist in implanting the system.
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