BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    PMA: P010014 · Supplement: S009 · Decision Jul 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
    Trade Name
    OXFORD MENISCAL UNICOMPARTMENTAL KNEE
    PMA Number
    P010014
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    NRA
    Generic Name
    Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 2006
    Date Received
    July 3, 2006
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PROCESS SPECIFICATIONS FOR THE 9-STAGE KERRY CLEANING PLANT USED IN THE ULTRASONIC CLEANING OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM METALLIC COMPONENTS (FEMORAL AND TIBIAL). THE CHANGES REQUIRE DETAILED MONITORING OF THE ULTRASONIC EQUIPMENT TO ENSURE THE ADEQUACY OF ITS OUTPUT.

    Classifications

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

    Product Code Device Name
    NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing