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

    TransLoc 3D

    K Number: K211496 · Decision Jul 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    2
    Review Days
    440

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    Basic Information

    Device Name
    TransLoc 3D
    K Number
    K211496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foundation Fusion Solutions, LLC (Dba Cornerloc)
    Date Received
    May 13, 2021
    Decision Date
    July 27, 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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    Other Clearances by Foundation Fusion Solutions, LLC (Dba Cornerloc)

    K Number Device Name
    K232878 TransLoc 3D