BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    neon3™ universal OCT spinal stabilization

    K Number: K161032 · Decision Dec 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    24
    Review Days
    253

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    Basic Information

    Device Name
    neon3™ universal OCT spinal stabilization
    K Number
    K161032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ulrich GmbH & Co. KG
    Date Received
    April 13, 2016
    Decision Date
    December 22, 2016
    Product Code
    NKG
    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
    NKG Posterior Cervical Screw System

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