BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Premier

    K Number: K160320 · Decision Apr 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    354
    Registration Numbers
    354
    Same Product Code
    302
    Applicant Total
    1
    Review Days
    56

    Basic Information

    Device Name
    Premier
    K Number
    K160320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Weigao Orthopaedic Device Co., Ltd
    Date Received
    February 5, 2016
    Decision Date
    April 1, 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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