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

    INTRAMEDULLARY NAIL SYSTEM

    K Number: K122994 · Decision Apr 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    5
    Review Days
    197

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    Basic Information

    Device Name
    INTRAMEDULLARY NAIL SYSTEM
    K Number
    K122994
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Weigao Orthopaedic Device Co., Ltd.
    Date Received
    September 27, 2012
    Decision Date
    April 12, 2013
    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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    Other Clearances by Weigao Orthopaedic Device Co., Ltd.

    K Number Device Name
    K133053 MILESTONE SPINAL SYSTEM
    K130340 LOCKING BONE PLATES AND SCREWS
    K123578 ANTERIOR CERVICAL PLATE SYSTEM
    K121312 INTRAMEDULLARY NAIL SYSTEM