BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇭 Thailand

    GPS, G SURGICAL PEDICLE SYSTEM

    K Number: K081041 · Decision Jun 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    GPS, G SURGICAL PEDICLE SYSTEM
    K Number
    K081041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G Surgical Co., Ltd.
    Date Received
    April 11, 2008
    Decision Date
    June 27, 2008
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by G Surgical Co., Ltd.

    K Number Device Name
    K103070 GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +