BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

    PMA: P090002 · Supplement: S007 · Decision Dec 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
    Trade Name
    PINNACLE COMPLETE ACETABULAR HIP SYSTEM
    PMA Number
    P090002
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    OVO
    Generic Name
    Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2012
    Date Received
    November 28, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PRODUCT LABELING/ INFORMATION FOR USE FOR THE DEVICE.

    Classifications

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

    Product Code Device Name
    OVO Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation