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510(k) Data Aggregation

    K Number
    K023983
    Device Name
    MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
    Date Cleared
    2003-09-22

    (294 days)

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

    HIGHGATE ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
    Device Description
    The Highgate Curved Rod System is available in titanium alloy (Ti6Al4V, ASTM F136) and includes rods and screws. Screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.
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    K Number
    K012045
    Device Name
    HIGHGATE CURVED ROD SYSTEM
    Date Cleared
    2002-03-12

    (256 days)

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

    HIGHGATE ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from To to L5. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
    Device Description
    The Highgate Curved Rod System is available in titanium alloy (Ti6A14V, ASTM F136) and includes rods and screws. Lateral and end screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.
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