BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Posterior Spinal Elements

    PMA: P220002 · Supplement: S001 · Decision Aug 11, 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
    S001
    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
    August 11, 2023
    Date Received
    July 14, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) protocol.

    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