BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Renaissance X System

    Reg #: 3012911444 · FEI: 3012911444 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TAMUZ F.T.K. SOLUTIONS
    Registration Number
    3012911444
    FEI Number
    3012911444
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kibbutz Yizrael
    City
    Afula Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K152041

    Owner / Operator

    Firm Name
    Tamuz F.T.K. Solutions
    Operator Number
    10060855
    Address
    Kibbutz Yizrael
    City
    Afula
    State
    IL-NOTA
    Postal Code
    19350
    Country
    IL
    Correspondent
    George Hattub

    US Agent

    Business Name
    Medicsense USA
    Contact Name
    George Hattub
    Address
    291 Hillside Avenue
    City
    Somerset
    State
    MA
    ZIP
    02726
    Country
    US
    Email
    [email protected]
    Phone
    508 4796116

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Neurological Stereotaxic Instrument HAW
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Renaissance X System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)