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

    REVOLUTION SPINAL FIXATION SYSTEM

    K Number: K032219 · Decision Dec 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    1
    Review Days
    151

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    Basic Information

    Device Name
    REVOLUTION SPINAL FIXATION SYSTEM
    K Number
    K032219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spinal Innovations, Inc.
    Date Received
    July 21, 2003
    Decision Date
    December 19, 2003
    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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