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510(k) Data Aggregation

    K Number
    K152662
    Device Name
    S-Wire
    Manufacturer
    Spinal Resources Inc
    Date Cleared
    2016-03-09

    (174 days)

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

    Spinal Resources Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.
    Device Description
    The S-Wire is composed of wires manufactured from stainless steel per ASTM F138 and nitinol per ASTM F2063. The wires are available in lengths of 150-550mm and diameters of .7-1.6mm. The S-wire is available with the following tip styles: Diamond Smooth, Diamond Threaded, Round Smooth, Round Threaded, Trocar Smooth, Trocar Threaded, and Diamond Suture Passer.
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