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

    Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

    K Number: K242464 · Decision Jun 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    370
    Registration Numbers
    370
    Same Product Code
    404
    Applicant Total
    8
    Review Days
    290

    Basic Information

    Device Name
    Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
    K Number
    K242464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Navigation, Inc.
    Date Received
    August 19, 2024
    Decision Date
    June 5, 2025
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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