BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    GSS PEDICLE SCREW SYSTEM

    K Number: K053573 · Decision Mar 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    18
    Review Days
    76

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    Basic Information

    Device Name
    GSS PEDICLE SCREW SYSTEM
    K Number
    K053573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GS Medical Co., Ltd.
    Date Received
    December 22, 2005
    Decision Date
    March 8, 2006
    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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    K200592 GS Medical AnyPlus PEEK Cage System
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