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

    MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM

    K Number: K080075 · Decision Jan 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    4
    Review Days
    17

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    Basic Information

    Device Name
    MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
    K Number
    K080075
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elite Surgical Supplies (Pty), Ltd.
    Date Received
    January 11, 2008
    Decision Date
    January 28, 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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