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

    MODIFICATION TO 4CIS VANE SPINE SYSTEM

    K Number: K081145 · Decision Nov 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    17
    Review Days
    197

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    Basic Information

    Device Name
    MODIFICATION TO 4CIS VANE SPINE SYSTEM
    K Number
    K081145
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solco Biomedical Co., Ltd.
    Date Received
    April 22, 2008
    Decision Date
    November 5, 2008
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

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    Other Clearances by Solco Biomedical Co., Ltd.

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