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

    CERTEX OCT SPINAL IMPLANT SYSTEM

    K Number: K133094 · Decision Dec 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    34
    Review Days
    72

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    Basic Information

    Device Name
    CERTEX OCT SPINAL IMPLANT SYSTEM
    K Number
    K133094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    X-Spine Systems, Inc.
    Date Received
    September 30, 2013
    Decision Date
    December 11, 2013
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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