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510(k) Data Aggregation

    K Number
    K050997
    Device Name
    EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
    Manufacturer
    Date Cleared
    2005-10-07

    (170 days)

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

    FLEXUSPINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EXPANSE Vertebral Body Replacement (VBR) Device is indicated for use in the thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body which has been resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The EXPANSE VBR Device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The EXPANSE VBR Device is intended to be used with bone graft and supplemental fixation. The supplemental internal fixation systems that may be used with the EXPANSE VBR Device include the Zodiac Polyaxial Pedicle Screw System, the Expedium Spinal System, the Expedium Anterior system, and the CD Horizon Spinal System, or equivalent systems. The EXPANSE VBR Device may be implanted singularly or in pairs.
    Device Description
    The EXPANSE device is manufactured from implantable grade titanium 6Al-4V alloy that conforms to ASTM F- 136. The device consists of opposing surfaces that make contact with the bony endplates of the vertebral bodies and can be expanded 2 mm in height. Following expansion, a shim is inserted between the opposing surfaces to provide mechanical integrity of the implanted device. Each surface in contact with the bony endplates is roughened to provide positive engagement with the endplates to resist rotation and migration. The EXPANSE is offered in five heights and a single length to provide the surgeon anatomic flexibility.
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