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

    DRX9000C-SL Cervical Spinal Decompression System

    K Number: K243366 · Decision Jun 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    233

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    Basic Information

    Device Name
    DRX9000C-SL Cervical Spinal Decompression System
    K Number
    K243366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excite Medical of Tampa Bay, LLC
    Date Received
    October 28, 2024
    Decision Date
    June 18, 2025
    Product Code
    ITH
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITH Equipment, Traction, Powered

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    Other Clearances by Excite Medical of Tampa Bay, LLC

    K Number Device Name
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