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510(k) Data Aggregation

    K Number
    K170855
    Device Name
    T-Rex Standalone ALIF
    Manufacturer
    SIATS, LLC
    Date Cleared
    2017-09-07

    (169 days)

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

    SIATS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
    Device Description
    The T-Rex™ Standalone ALIF is a lumbar Intervertebral Body Fusion Device with integrated fixation made from HA Enhanced PEEK-OPTIMA (HAPEEK) incorporating titanium bone screws. The implants are available in various heights, widths, lengths, and angles of lordosis to accommodate patients' anatomy. The implants are provided sterile with surgical instruments provided non-sterile to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), are included in each implant to allow radiographic visualization.
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