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

    INTRAMEDULLARY NAIL SYSTEM

    K Number: K121312 · Decision Oct 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    5
    Review Days
    176

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    Basic Information

    Device Name
    INTRAMEDULLARY NAIL SYSTEM
    K Number
    K121312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Weigao Orthopaedic Device Co., Ltd.
    Date Received
    May 1, 2012
    Decision Date
    October 24, 2012
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by Weigao Orthopaedic Device Co., Ltd.

    K Number Device Name
    K133053 MILESTONE SPINAL SYSTEM
    K122994 INTRAMEDULLARY NAIL SYSTEM
    K130340 LOCKING BONE PLATES AND SCREWS
    K123578 ANTERIOR CERVICAL PLATE SYSTEM