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510(k) Data Aggregation

    K Number
    K142134
    Device Name
    C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES
    Date Cleared
    2014-09-12

    (39 days)

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

    CONMED CORPORATION, LARGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.
    Device Description
    The C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats. The C-Wire Double Ended Orthopedic Wires are single-use devices that are indicated for surgical repair of small bone trauma. The C-Wires provide mechanical stability during the natural bone healing process. Each wire is 5" (127mm) long, with each end ground to either a spade or trocar shaped tip. C-Wires are available in four different diameters (0.7mm, 0.89mm, 1.14mm and 1.57mm). The wires are made of 316LVM stainless steel.
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