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510(k) Data Aggregation

    K Number
    K113755
    Device Name
    SAVANNAH TECHNOLOGIES SPINAL SYSTEM
    Date Cleared
    2012-02-01

    (42 days)

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

    SAVANNAH TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Savannah Technologies Spinal 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a pedicle screw system, the Savannah Technologies Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
    Device Description
    The Savannah Technologies Spinal System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively. The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. The rods are available in multiple lengths. The system has cross linkage assemblies to supply torsional stability to the construct. Materials: The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and ISO 5832-3. Function: The Savannah Technologies Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.
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