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

    LOCKING BONE PLATES AND SCREWS

    K Number: K130340 · Decision Apr 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    53

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    Basic Information

    Device Name
    LOCKING BONE PLATES AND SCREWS
    K Number
    K130340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Weigao Orthopaedic Device Co., Ltd.
    Date Received
    February 11, 2013
    Decision Date
    April 5, 2013
    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 Weigao Orthopaedic Device Co., Ltd.

    K Number Device Name
    K133053 MILESTONE SPINAL SYSTEM
    K122994 INTRAMEDULLARY NAIL SYSTEM
    K123578 ANTERIOR CERVICAL PLATE SYSTEM
    K121312 INTRAMEDULLARY NAIL SYSTEM