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    K Number
    K140088
    Device Name
    PHANTOM XL INSULATED DILATORS
    Manufacturer
    TEDAN SURGICAL INNOVATIONS, LLC
    Date Cleared
    2014-09-25

    (254 days)

    Product Code
    PDQ
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEDAN SURGICAL INNOVATIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.
    Device Description
    Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes (8, 13, 18, 22 and 22mm Grooved). They are supplied sterile, are non-pyrogenic, and are intended for single use only. The 8 mm dilators are made of stainless steel and are visible under fluoroscopy, while the remaining sizes are made of aluminum alloy and are radiolucent.
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