BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ANTERIOR CERVICAL PLATE SYSTEM

    K Number: K123578 · Decision Feb 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    5
    Review Days
    73

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    Basic Information

    Device Name
    ANTERIOR CERVICAL PLATE SYSTEM
    K Number
    K123578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Weigao Orthopaedic Device Co., Ltd.
    Date Received
    November 20, 2012
    Decision Date
    February 1, 2013
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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    Other Clearances by Weigao Orthopaedic Device Co., Ltd.

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