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

    NGARDE SYSTEM

    K Number: K072685 · Decision Oct 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    NGARDE SYSTEM
    K Number
    K072685
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    N Spine, Inc.
    Date Received
    September 21, 2007
    Decision Date
    October 19, 2007
    Product Code
    NQP
    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
    NQP Posterior Metal/Polymer Spinal System, Fusion

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