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510(k) Data Aggregation

    K Number
    K170475
    Device Name
    SICAGE™ System
    Manufacturer
    Sicage LLc
    Date Cleared
    2017-05-05

    (78 days)

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

    Sicage LLc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SICAGE is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacrollitis.
    Device Description
    SICAGE is a fully threaded bone screw offered in a single diameter and various lengths to accommodate variability in patient anatomy. SICAGE is sold sterile. The SICAGE System includes implants and instruments for implantation.
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