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

    CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments

    K Number: K191835 · Decision Aug 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    172
    Review Days
    28

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    Basic Information

    Device Name
    CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
    K Number
    K191835
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Globus Medical, Inc.
    Date Received
    July 9, 2019
    Decision Date
    August 6, 2019
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Globus Medical, Inc.

    K Number Device Name
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    K250599 ExcelsiusGPS™ Instruments
    K251161 ANTHEM® Fracture System
    K241525 ExcelsiusXR™
    K243456 ONVOY™ Acetabular System
    K243814 NuVasive Pulse System
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