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510(k) Data Aggregation

    K Number
    K132310
    Device Name
    ASCOT
    Date Cleared
    2013-12-23

    (151 days)

    Product Code
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    BACKROADS CONSULTING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ASCOT® is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
    Device Description
    ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/diameter combinations. In addition, a center graft screw is offered.
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