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

    Skyway Anterior Cervical Plate System

    K Number: K250486 · Decision Apr 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    655
    Applicant Total
    2
    Review Days
    50

    Basic Information

    Device Name
    Skyway Anterior Cervical Plate System
    K Number
    K250486
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kyocera Medical Technologies, Inc. (KMTI)
    Date Received
    February 19, 2025
    Decision Date
    April 10, 2025
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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    Other Clearances by Kyocera Medical Technologies, Inc. (KMTI)

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