BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    PMA: P190009 · Supplement: S004 · Decision Dec 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
    Trade Name
    OPRA Implant System
    PMA Number
    P190009
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    PJY
    Generic Name
    Osseoanchored prostheses for the rehabilitation of transfemoral amputees
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2023
    Date Received
    September 25, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Your supplement requested approval for material changes from Oilon to PEEK for the bending and torque punch components of Axor II, OPRA Implant System.

    Classifications

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

    Product Code Device Name
    PJY Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees