BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SILO TFX MIS Sacroiliac Joint Fixation System

    K Number: K221047 · Decision Oct 3, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    7
    Review Days
    178

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    Basic Information

    Device Name
    SILO TFX MIS Sacroiliac Joint Fixation System
    K Number
    K221047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aurora Spine, Inc.
    Date Received
    April 8, 2022
    Decision Date
    October 3, 2022
    Product Code
    OUR
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OUR Sacroiliac Joint Fixation

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