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510(k) Data Aggregation

    K Number
    K171558
    Device Name
    ExsoMed ITN Cannulated Screw System
    Manufacturer
    Exsomed Holdings Company, LLC
    Date Cleared
    2017-09-01

    (94 days)

    Product Code
    HWC
    Regulation Number
    888.3040
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    Applicant Name (Manufacturer) :

    Exsomed Holdings Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExsoMed ITN Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
    Device Description
    The ExsoMed ITN Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The headless design of the screw allows for the screw to be countersunk below the surface of the bone. The screws are offered in one thread diameter (4.0mm distal / 4.5mm proximal) and lengths between 35 and 75mm. The screws are designed for permanent implantation. Screw implantation is facilitated by the use of three accessory devices provided in a separate procedure kit: • A K-wire to be used as a guide • A cannulated reamer to be used over the K-wire to create the desired pilot hole • A depth gauge to determine the appropriate screw length prepare the medullary cavity • A cannulated hexalobe driver
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