BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050016 · Supplement: S006 · Decision Dec 31, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
    Trade Name
    CORMET HIP RESURFACING SYSTEM
    PMA Number
    P050016
    Supplement Number
    S006
    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
    December 31, 2009
    Date Received
    November 2, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE METHOD OF STERILIZATION OF THE INDIVIDUALLY PACKAGED FLUTED GUIDE WIRE AND REVISIONS TO THE PACKAGE LABELING.

    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