BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    PMA: P030022 · Supplement: S036 · Decision Jul 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
    Trade Name
    REFLECTION CERAMIC ACETABULAR HIP SYSTEM
    PMA Number
    P030022
    Supplement Number
    S036
    Device Class
    FDA Class 3
    Product Code
    MRA
    Generic Name
    Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 22, 2016
    Date Received
    June 23, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a labeling change for the REFLECTION Ceramic Acetabular Hip System which also includes the R3 Ceramic Acetabular Hip System.

    Classifications

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

    Product Code Device Name
    MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented