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

    Ball Joint Guide Array (66295)

    K Number: K250893 · Decision Sep 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    10
    Review Days
    163

    Basic Information

    Device Name
    Ball Joint Guide Array (66295)
    K Number
    K250893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Medical Care, Inc.
    Date Received
    March 25, 2025
    Decision Date
    September 4, 2025
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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