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510(k) Data Aggregation

    K Number
    K232069
    Device Name
    Expandable Lumbar Fusion Cage (Type I,Type II)
    Date Cleared
    2023-11-29

    (140 days)

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

    Shanghai REACH Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Expandable Lumbar Fusion Cage (Type I , Type II ) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine(L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable Lumbar Fusion Cage (Type II) are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Posterior Spinal Fixation System.
    Device Description
    The Expandable Lumbar Fusion Cage system is a kind of fusion device for thoracolumbar and spinal stability. The main indication of this product is spinal fusion for spinal operation. The components of system are made of titanium alloy. The Expandable Lumbar Fusion Cage system is used by trained orthopaedic surgeons and/or neurosurgeons in a standard operating environment. The Expandable Lumbar Fusion Cage system provides a wide range of implants, including different widths, heights, lengths and angles to choose from.
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