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    K Number
    K152732
    Device Name
    AOS Small Fragment Plating System
    Manufacturer
    AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
    Date Cleared
    2015-12-10

    (79 days)

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

    AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AOS Small Fragment Plating System is intended to be used for fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, including osteopenic bone.
    Device Description
    The AOS Small Fragment Plating System consists of titanium plates in various configurations and sizes. The system includes non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.
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