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

    Prosthesis, Posterior Spinal Elements

    PMA: P220002 · Supplement: S010 · Decision Oct 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Posterior Spinal Elements
    Trade Name
    TOPS™ System
    PMA Number
    P220002
    Supplement Number
    S010
    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
    October 29, 2025
    Date Received
    September 30, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    introduction of a new plug sorting jig, adjustment to the plug cutting and insertion machine, and minor dimensional changes to the plug and top plate components to and improve sealing performance at the Premia Spine Ltd, Ramat Poleg, Netanya, Isreal and TAV Medical Ltd, Israel facilities

    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