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

    CD HORIZON Growth Rod Conversion Set

    K Number: K150200 · Decision Feb 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    CD HORIZON Growth Rod Conversion Set
    K Number
    K150200
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Incorporated
    Date Received
    January 29, 2015
    Decision Date
    February 25, 2015
    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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    Other Clearances by Medtronic Sofamor Danek USA, Incorporated

    K Number Device Name
    K152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set