BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ANYPLUS PEEK CAGES

    K Number: K100516 · Decision Dec 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    18
    Review Days
    283

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    Basic Information

    Device Name
    ANYPLUS PEEK CAGES
    K Number
    K100516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GS Medical Co., Ltd.
    Date Received
    February 23, 2010
    Decision Date
    December 3, 2010
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

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    Other Clearances by GS Medical Co., Ltd.

    K Number Device Name
    K243073 AnyPlus Navigated Instruments System
    K241738 PYXIS 3D Titanium Cervical Cage system
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    K231808 QUASAR Standalone ACIF System
    K223868 PYXIS 3D Titanium Cage System
    K222041 CYGNUS-C Standalone ACIF System
    K221687 Pegasus-X Expandable PLIF System
    K211797 TRACKER Plus Kyphoplasty System
    K200592 GS Medical AnyPlus PEEK Cage System
    K192335 TRACKER Kyphoplasty System
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