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510(k) Data Aggregation

    K Number
    K232149
    Device Name
    BowTie™ SI Joint Fusion System
    Manufacturer
    SAIL Fusion, LLC
    Date Cleared
    2024-04-20

    (276 days)

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

    SAIL Fusion, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Bow Tie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.
    Device Description
    The BowTie™ SI Joint Fusion System is intended to provide stabilization of the sacroiliac joint until fusion occurs. The device consists of an implant and a set of ancillary instruments. The implant is comprised of an interarticular component, an iliac screw, and a transfix screw. All implant components are titanium and available in various sizes to accommodate varying patient anatomy. The implant components are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and will be sterilized by the end user.
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