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

    SafeOp 3: Neural Informatix Systeem

    K Number: K234092 · Decision Apr 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    93
    Review Days
    115

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    Basic Information

    Device Name
    SafeOp 3: Neural Informatix Systeem
    K Number
    K234092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Spine, Inc.
    Date Received
    December 26, 2023
    Decision Date
    April 19, 2024
    Product Code
    GWF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWF Stimulator, Electrical, Evoked Response

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