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510(k) Data Aggregation

    K Number
    K090303
    Device Name
    XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
    Date Cleared
    2009-04-30

    (83 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORESPINE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space. The XTEND-ST Nucleus Removal System is indicated to resect damaged or diseased intervertebral nucleus pulposus material found in the adult lumbar disc space.
    Device Description
    The CoreSpine XTEND-ST Nucleus Removal System is a soft tissue removal device that is comprised of a disposable, sterile handheid nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal. The tip of the XTEND-ST cutting device can articulate and extend within the disc cavity providing an ability to reach areas of the disc that are otherwise unreachable with a rongeur. Cut tissue is continuously suctioned through a central lumen using a standard vacuum designed to minimize clogging. The XTEND-ST Nucleus Removal System is intended to effectively and efficiently prepare the disc space without damaging the annulus or endplates in preparation for a spinal implant or other therapy. The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.
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