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510(k) Data Aggregation

    K Number
    K100037
    Device Name
    ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
    Date Cleared
    2010-09-23

    (260 days)

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

    ADVANCED VERTEBRAL SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Advanced Vertebral Solutions IBF device, when used with autologous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Advanced Vertebral Solutions IBF device is to be implanted via a transforaminal approach. The device is to be used singly in the lumbosacral spine with supplemental posterior fixation.
    Device Description
    Advanced Vertebral Solutions Express IBFD AVS Express is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces. Advanced Vertebral Solutions Express IBFD AVS Express is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Advanced Vertebral Solutions designed the Advanced Vertebral Solutions Express IBFD AVS Express to be placed through a transforaminal approach and to address vertebrae in the lumbosacral region of the spine.
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