BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P090002 · Supplement: S003 · Decision Apr 26, 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
    S003
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 26, 2012
    Date Received
    March 27, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE STERILE BARRIER PACKAGE SEALING PROCESS USED FOR THE CERAMIC FEMORAL HEADS AND ACETABULAR LINERS.

    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