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

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    K Number: K141278 · Decision Mar 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    13
    Review Days
    312

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    Basic Information

    Device Name
    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    K Number
    K141278
    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, Inc.
    Date Received
    May 16, 2014
    Decision Date
    March 24, 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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    Other Clearances by Ellipse Technologies, Inc.

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    K141447 PRECICE TRAUMA NAIL SYSTEM
    K141023 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K140178 ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    K131490 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K133289 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K131677 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K113219 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
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