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510(k) Data Aggregation

    K Number
    K150954
    Device Name
    Elite L Expandable Lumbar Fusion System
    Manufacturer
    INNOVA SPINAL TECHNOLOGIES, LLC
    Date Cleared
    2015-05-07

    (28 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVA SPINAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in sketetally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.
    Device Description
    The Elite™ L is a titanium alloy (Ti6Al4V-ELI) implant that is designed to provide mechanical support of the intradiscal space while biologic fusion occurs. The device is available in a variety of footprints, all of which are inserted in the unexpanded state and are expanded in situ. There are various heights to accommodate varied patients' anatomy. The implants are available in parallel and lordotic angles, with the implant end plates being bi-convex to optimize contact with the vertebral body end plates. All implants are made from medical grade titanium alloy. Implants have a locking mechanism to hold the implant in the expanded position once deployed.
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    K Number
    K133459
    Device Name
    ELITE IBF
    Manufacturer
    INNOVA SPINAL TECHNOLOGIES, LLC
    Date Cleared
    2014-03-06

    (114 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVA SPINAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELITE™ IBF Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-S1. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.
    Device Description
    Not Found
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