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

    SHILLA GROWTH GUIDANCE SYSTEM

    K Number: K140750 · Decision Jul 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    13
    Applicant Total
    171
    Review Days
    114

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    Basic Information

    Device Name
    SHILLA GROWTH GUIDANCE SYSTEM
    K Number
    K140750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Inc.
    Date Received
    March 25, 2014
    Decision Date
    July 17, 2014
    Product Code
    PGM
    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
    PGM Growing Rod System

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