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510(k) Data Aggregation

    K Number
    K122814
    Device Name
    GALLEON PEDICLE SCREW SYSTEM
    Manufacturer
    EVEREST SPINE, LLC
    Date Cleared
    2012-12-03

    (81 days)

    Product Code
    MNHMNI
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVEREST SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Everest Spine Galleon Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
    Device Description
    The Everest Spine Galleon Pedicle Screw System consists of longitudinal rods, polyaxial screws, and cross connectors. The Everest Spine Galleon Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.
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