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

    REX ANTERIOR CERVICAL PLATE SYSTEM

    K Number: K121862 · Decision Oct 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    7
    Review Days
    127

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    Basic Information

    Device Name
    REX ANTERIOR CERVICAL PLATE SYSTEM
    K Number
    K121862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dio Medical Co., Ltd.
    Date Received
    June 26, 2012
    Decision Date
    October 31, 2012
    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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