BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    LumFix Spinal Fixation Sytem

    K Number: K160731 · Decision Oct 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    354
    Registration Numbers
    354
    Same Product Code
    302
    Applicant Total
    1
    Review Days
    201

    Basic Information

    Device Name
    LumFix Spinal Fixation Sytem
    K Number
    K160731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CG BIO CO., LTD.
    Date Received
    March 17, 2016
    Decision Date
    October 4, 2016
    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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