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510(k) Data Aggregation

    K Number
    K112748
    Device Name
    SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    SPINAL USA LLC
    Date Cleared
    2012-07-11

    (294 days)

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

    SPINAL USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
    Device Description
    The Slimplicity Solo Anterior Cervical Plate System consists of an assortment of plates and screws. Each Slimplicity Solo plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). Slimplicity Solo implants are composed of titanium alloy, as specified in ASTM F136. The components will be provided non-sterile.
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