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

    ACPII ANTERIOR CERVICAL PLATE SYSTEM

    K Number: K970806 · Decision May 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    41
    Review Days
    58

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    Basic Information

    Device Name
    ACPII ANTERIOR CERVICAL PLATE SYSTEM
    K Number
    K970806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Sofamor Danek USA,Inc.
    Date Received
    March 5, 1997
    Decision Date
    May 2, 1997
    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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