BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Posterior Spinal Elements

    PMA: P220002 · Supplement: S005 · Decision Jan 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Prosthesis, Posterior Spinal Elements
    Trade Name
    TOPS System
    PMA Number
    P220002
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    QWK
    Generic Name
    Prosthesis, posterior spinal elements
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 17, 2025
    Date Received
    December 19, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to introduce three (3) semi-automated machines as alternatives to the current manual process for certain TOPS™ assembly steps at the established manufacturing facility in Netanya, Israel for enhanced reproducibility / reliability

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QWK Prosthesis, Posterior Spinal Elements