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

    Prosthesis, Posterior Spinal Elements

    PMA: P220002 · Supplement: S002 · Decision Sep 7, 2023
    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
    S002
    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
    September 7, 2023
    Date Received
    August 10, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Information provided by the firm to support the following changes: 1. The addition of two (2) semi-automated assembly machines (Boot to TOP Plate machine-EGEQ88244 and Core Assembly to TOP Plate-EGEQ88242), as alternative to the current manual process, for certain assembly steps of the TOPS; and 2) Flip the insertion orientation of the Polycarbonate Urethane (PcU) Plug prior to its insertion into the TOPS Top Plate.

    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