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

    MAGEC 2 Spinal Bracing and Distraction System

    K Number: K150885 · Decision May 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    MAGEC 2 Spinal Bracing and Distraction System
    K Number
    K150885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ellipse Technologies, Incorporated
    Date Received
    April 2, 2015
    Decision Date
    May 29, 2015
    Product Code
    PGN
    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
    PGN Growing Rod System- Magnetic Actuation

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