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

    EXTERNAL FIXATOR SYSTEM

    K Number: K122208 · Decision Dec 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    148

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    Basic Information

    Device Name
    EXTERNAL FIXATOR SYSTEM
    K Number
    K122208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Christopher D. Endara
    Date Received
    July 25, 2012
    Decision Date
    December 20, 2012
    Product Code
    NDK
    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
    NDK System, External Fixator (With Metallic Invasive Components)

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