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

    Zenius™, Iliad™ and Kora™ Spinal Fixation Systems

    K Number: K181978 · Decision Aug 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    19
    Review Days
    20

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    Basic Information

    Device Name
    Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
    K Number
    K181978
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medyssey USA, Inc.
    Date Received
    July 24, 2018
    Decision Date
    August 13, 2018
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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