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

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

    PMA: P010014 · Supplement: S067 · Decision Oct 5, 2017
    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 Partial Knee System - tibial tray and femoral components
    PMA Number
    P010014
    Supplement Number
    S067
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 5, 2017
    Date Received
    September 11, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Repeat of a specific manufacturing step if needed and allowing that data from erratic sensors not be used to accept or reject a production run provided other sensors co-located with the erratic sensor conform to specification.

    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