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

    Spinal fixation system

    K Number: K161151 · Decision Sep 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    338
    Registration Numbers
    338
    Same Product Code
    308
    Applicant Total
    2
    Review Days
    149

    Basic Information

    Device Name
    Spinal fixation system
    K Number
    K161151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CANWELL MEDICAL CO., LTD.
    Date Received
    April 25, 2016
    Decision Date
    September 21, 2016
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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