BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P090002 · Supplement: S005 · Decision Sep 6, 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
    S005
    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
    September 6, 2012
    Date Received
    August 3, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING.

    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