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

    TRAUSON BONE PLATE

    K Number: K073432 · Decision Aug 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    4
    Review Days
    251

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    Basic Information

    Device Name
    TRAUSON BONE PLATE
    K Number
    K073432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trauson (Jiangsu) Medical Instrument Co., Ltd.
    Date Received
    December 6, 2007
    Decision Date
    August 13, 2008
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Trauson (Jiangsu) Medical Instrument Co., Ltd.

    K Number Device Name
    K082617 TRAUSON GENERAL SPINAL SYSTEM (GSS)
    K081230 TRAUSON INTRAMEDULLARY NAIL
    K073159 TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5