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

    ULTIUM SPINAL PLATING SYSTEM

    K Number: K962784 · Decision Oct 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    10
    Review Days
    77

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    Basic Information

    Device Name
    ULTIUM SPINAL PLATING SYSTEM
    K Number
    K962784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Smith & Nephew, Inc., Orthopaedic Div.
    Date Received
    July 17, 1996
    Decision Date
    October 2, 1996
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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