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

    Metallic Locking Bone Plate and Screw System

    K Number: K143002 · Decision Jun 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    2
    Review Days
    228

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    Basic Information

    Device Name
    Metallic Locking Bone Plate and Screw System
    K Number
    K143002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Changzhou Dingjian Medical Appliance Co., Ltd.
    Date Received
    October 20, 2014
    Decision Date
    June 5, 2015
    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 Changzhou Dingjian Medical Appliance Co., Ltd.

    K Number Device Name
    K143013 Spinal Inner Fixation System