BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Posterior Spinal Elements

    PMA: P220002 · Supplement: S006 · Decision Mar 25, 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
    S006
    Device Class
    FDA Class 3
    Product Code
    QWK
    Generic Name
    Prosthesis, posterior spinal elements
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 25, 2025
    Date Received
    December 26, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of additional pedicle screw components (CD Horizon Solera Ø6.5-7.5mm non-cannulated, multi-axial pedicle screws with lengths from 25-60mm manufactured by Medtronic Sofamor Danek USA, Inc.) with the TOPS™ System

    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