BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    PMA: P040033 · Supplement: S025 · Decision Aug 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
    Trade Name
    BIRMINGHAM HIP RESURFACING SYSTEM
    PMA Number
    P040033
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    NXT
    Generic Name
    Prosthesis, hip, semi-constrained, metal/metal, resurfacing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 12, 2014
    Date Received
    May 14, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITION TO THE LABELING FOR THE BIRMINGHAM HIPRESURFACING (BHR) SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.

    Classifications

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

    Product Code Device Name
    NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing