BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    4CIS® Pinehurst Anterior Cervical Plate system

    K Number: K182489 · Decision Jan 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    17
    Review Days
    127

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    Basic Information

    Device Name
    4CIS® Pinehurst Anterior Cervical Plate system
    K Number
    K182489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solco Biomedical Co., Ltd.
    Date Received
    September 11, 2018
    Decision Date
    January 16, 2019
    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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