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    K Number
    K190580
    Device Name
    NADIA SI Fusion System
    Manufacturer
    Ilion Medical Inc
    Date Cleared
    2020-08-05

    (518 days)

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

    Ilion Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NADIA SI Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The NADIA SI Fusion System is intended to provide support and structural stability during sacroiliac fusion surgery. The NADIA sacroiliac (SI) fusion system consist of different sizes of lattice fenestrated screws that accept cannulated instruments. NADIA screws are manufactured from titanium alloy per ASTM F136 and will be provided gamma sterilized. The screws are available in multiple lengths and diameters and are provided either uncoated or coated with hydroxyapatite. Instrumentation necessary for proper implantation is also included.
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