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510(k) Data Aggregation

    K Number
    K051697
    Device Name
    SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
    Date Cleared
    2005-09-21

    (90 days)

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

    MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.
    Device Description
    The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.
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