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510(k) Data Aggregation

    K Number
    K181881
    Device Name
    Outlet Sacroiliac Joint Fusion System
    Manufacturer
    SIJ Surgical
    Date Cleared
    2018-10-03

    (82 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIJ Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Outlet Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The Outlet Sacroiliac Joint Fusion System consists of cannulated, fully threaded screws with double helix threads designed to be able to screw into pre-drilled bone. It is fabricated from medical grade titanium alloy, Ti-6AI-4V (ASTM F-136). The Outlet System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
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