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510(k) Data Aggregation

    K Number
    K121786
    Device Name
    DYMAXEON SPINE SYSTEM
    Manufacturer
    B2B SPINE PTY LTD
    Date Cleared
    2012-11-05

    (140 days)

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

    B2B SPINE PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
    Device Description
    The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of polyaxial pedicle screws, reduction screws, and rods. The Dymaxeon Spine System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters.
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