Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071151
    Device Name
    TENSION BAND ANTERIOR SPINAL SYSTEM
    Date Cleared
    2007-11-07

    (196 days)

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

    SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tension Band Anterior Spinal System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T7 to L5. The TBA Spinal System is intended to provide stabilization of a spinal segment(s) as an adjunct to spinal fusion. Indications for the use of this device include trauma, spinal stenosis, deformities or curvatures (e.g., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
    Device Description
    The Tension Band Anterior (TBA) Spinal System includes rods, hooks, wedges, and bone (vertebral) and lockdown screws. A single rod diameter and a range of hook sizes with size-matched bone screws are available. Wedges and lockdown screws serve as the interconnection mechanism.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1