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510(k) Data Aggregation

    K Number
    K112429
    Device Name
    GIZA(R) VERTEBRAL BODY REPLACEMENT
    Manufacturer
    EDEN SPINE, LLC
    Date Cleared
    2012-01-26

    (156 days)

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

    EDEN SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Giza® Vertebral Body Replacement is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g. fracture). The Giza® Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft with the Giza® Vertebral Body Replacement device is optional.
    Device Description
    The Giza® is a thoracolumbar vertebral body replacement device. The Giza is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and associated instrumentation. The devices are available in three diameters, 14mm, 21mm and 27mm. The Giza® device can accommodate lordosis from 2-12 degrees and from18 mm to 90mm in height. . All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
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