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510(k) Data Aggregation

    K Number
    K200834
    Device Name
    Lever Action Plate System
    Date Cleared
    2020-06-25

    (87 days)

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

    McGinley Orthpaedic Innovations, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lever Action Plate System is indicated for: 1. Fixation of fractures or non-unions of the distal radius 2. Osteotomies of the distal radius to correct malunion
    Device Description
    The Lever Action Plate System is a distal radius plate implanted in the treatment of distal radius fractures, non-unions, or osteotomies. The system consists of the plates, screws, beams, beam screws and instrumentation. The plates have either 1 or 2 beam slots which allow for implantation of the beams into the distal radius bone. The beams and their supporting beam screws are intended for maintaining volar correction intra-operatively. The plate and beam(s) are used in conjunction with screws and beam screws to fixate fragments in the wrist. The implants are composed of Ti-6Al-4V and are available in multiple configurations and sizes.
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