BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P200022 · Supplement: S012 · Decision Feb 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    Simplify Disc
    PMA Number
    P200022
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    MJO
    Generic Name
    Prosthesis, intervertebral disc
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 18, 2025
    Date Received
    October 16, 2023
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes to the cleaning process of the coated endplates at DOT GmbH to automated cleaning, an added oscillating movement, improved ultrasonic oscillator distribution, and an added rinsing step

    Classifications

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

    Product Code Device Name
    MJO Prosthesis, Intervertebral Disc