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    K Number
    K200868
    Device Name
    SI-Restore Sacroiliac Joint Fixation System
    Manufacturer
    Biofusion Medical
    Date Cleared
    2020-04-17

    (16 days)

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

    Biofusion Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation Screw is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The SI-Restore® Sacroiliac Joint Fixation Screw consists of a cannulated, smooth or textured, titanium (Ti 6Al-4V ELI, per ATSM F136) screw with a titanium (Ti 6Al-4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation and placement of the implant.
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    K Number
    K182919
    Device Name
    SI-Restore® Sacroiliac Joint Fixation System
    Manufacturer
    Biofusion Medical
    Date Cleared
    2019-01-25

    (98 days)

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

    Biofusion Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The SI-Restore® Sacroiliac Joint Fixation System consists of a cannulated titanium (Ti 6AI4V ELI, per ATSM F136) screw with a titanium (Ti 6AI4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The Implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation for and placement of the implant.
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