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    K Number
    K171407
    Device Name
    ExsoMed ArcPhix and ExsoMed ArrowPhix
    Manufacturer
    ExsoMed Holding Company, LLC
    Date Cleared
    2017-08-18

    (98 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ExsoMed Holding Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ExsoMed ArcPhix and ArrowPhix are indicated for use in the surgical fixation of small bones, bone fragments, and osteotomies. The devices are not indicated for soft tissue fixation.
    Device Description
    The Exsomed Small Screw system are stainless steel compression bone screws contained in sterile procedure kits. The ArcPhix screws are offered in two lengths, 28mm or 36mm by 3.2mm with an 18-degree bend. The ArrowPhix is a straight screw 26mm by 2.5mm. Implantation is facilitated by use of accessories provided in a sterile kit: • Implant • K-wire used as a guide Drill to prepare the bones to receive the implant Hexalobe driver for insertion of the bone screw
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