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510(k) Data Aggregation

    K Number
    K151312
    Device Name
    VerteLP Interbody Fusion Device
    Manufacturer
    Date Cleared
    2016-01-13

    (240 days)

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

    VGI, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VerteLP is indicated for use in skeletally mature patients with Degenerative Disc Discase (DDD) at one or two contiguous levels from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is intended to be used with supplemental fixation to the integrated fixation jaws, and must be used with autograft bone.
    Device Description
    The Vertel.P implant is an Intervertebral Body Fusion Device (IBFD) intended to be used in the lumbar spine via a lateral surgical approach. It is intended to stabilize a spinal segment to promote fusion between adjacent vertebral bodies. It also provides indirect decompression to relieve constricted nerve roots. Center apertures have been designed into the VerteLP implant for placement of bone graft to promote fusion through the center of the implant. The device has integrated fixation in the form of laterally- locking jaws to facilitate additional stability. VerteLP is available in a variety of sizes and shapes in order to better accommodate each patient's unique anatomy. The implant is made from Ti6Al4V alloy per ASTM F-136, Zeniva PEEK ZA-500 per ASTM F2026, UHMWPE per ASTM F648 and tantalum per ASTM F560. The devices are available in two widths, heights from 7-17mm and in both parallel and lordotic shapes to accommodate varied patient's anatomy.
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