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510(k) Data Aggregation

    K Number
    K161755
    Device Name
    Integrity-SI TM Fusion System
    Manufacturer
    CoorsTek Medical
    Date Cleared
    2016-12-14

    (170 days)

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

    CoorsTek Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integrity-SI™ Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The Integrity-SI™ Fusion System consists of partially and fully threaded, self-tapping cannulated titanium (Ti-6Al-4V ELI per ASTM F136) implants designed to be inserted across sacroiliac joint to provide stability for joint arthrodesis. The surgical implants are available in various sizes to accommodate patient anatomy. The 10mm and 12mm diameter screws are offered in and partially and fully threaded versions in lengths ranging from 40-110mm, in 5mm increments. All screw sizes are available in non-coated or hydroxyapatite-coated (HA) versions. The 10mm and 12mm screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5mm diameter, optional secondary screws are offered from lengths of 30 - 70 mm, in 5mm increments. All implants are provided sterile and are individually packaged. The 6.5 mm screws are not for use without the subject 10 mm or 12 mm screws.
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