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

    Triton™ Sacroiliac Joint Fixation System

    K Number: K211449 · Decision Aug 31, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    9
    Review Days
    113

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    Basic Information

    Device Name
    Triton™ Sacroiliac Joint Fixation System
    K Number
    K211449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choice Spine, LLC
    Date Received
    May 10, 2021
    Decision Date
    August 31, 2021
    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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