BEUDAMED
    Eu Mdd Eu Md Class 2a On The Market 🇩🇪 Germany

    Instruments and Trial Tray for Biotech Sterile Knee Endoprosthesis Systems

    Biotech GmbH · 🇩🇪 Germany
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    6
    Notified Bodies
    1

    Basic Information

    Primary DI
    D-4049852KN2DQUN
    Basic UDI-DI Code
    B-4049852KN2DQUN
    Reference
    4049852KN2DQ
    Device Types
    Sterilization
    Regulation
    Eu Mdd
    Classification
    Eu Md Class 2a
    Status
    On The Market
    Manufacturer
    Biotech GmbH

    Additional Description

    Trial elements and instrument set accessories for the surgical implantation/removal and revision of the "Biotech Sterile Knee Endoprosthesis Systems". The trial elements are used to support the selection of the appropriate device element with the size matching the anatomical needs of the patient, during the implantation of system elements. The instruments are required for the implantation or removal of the system elements, by temporary connection with the device during implantation or revision.

    CND Nomenclature Codes

    Code Description
    P09098099 KNEE PROSTHESES - ACCESSORIES - OTHER
    P0909800602 KNEE PROSTHESES TIBIAL STEMS
    P0909800601 KNEE PROSTHESES FEMORAL STEMS
    P09098004 KNEE PROSTHESES CENTRALISERS
    P09098003 KNEE PROSTHESES OBTURATORS AND PLUGS
    P09098002 KNEE PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES)
    P09098001 KNEE PROSTHESES AUGMENTS

    Certificates

    Type Number
    MDD Annex II (excluding section 4) No. 5-903-200-2103

    Available In Countries

    🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇭🇷 Croatia 🇭🇺 Hungary 🇹🇷 Türkiye

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