BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

    K Number: K153716 · Decision May 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    2
    Review Days
    145

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    Basic Information

    Device Name
    GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
    K Number
    K153716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gpc Medical, Ltd.
    Date Received
    December 24, 2015
    Decision Date
    May 17, 2016
    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 Gpc Medical, Ltd.

    K Number Device Name
    K092493 GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM