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    K Number
    K161913
    Device Name
    AOS Small Fragment Plating System
    Manufacturer
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
    Date Cleared
    2016-11-04

    (115 days)

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

    ADVANCED 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, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
    Device Description
    The AOS Small Fragment Plating System consists of titanium plates, screws, and washers in various configurations and sizes. The system includes Kirschner wires, non-locking screws in diameters of 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameters of 2.7mm, and 3.5mm. The plate system includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.
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