BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Localizer K-Wire

    Reg #: 3010313588 · FEI: 3010313588 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Fiagon GMBH
    Registration Number
    3010313588
    FEI Number
    3010313588
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Neuendorfstr. 23b
    City
    Hennigsdorf Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K230700

    Owner / Operator

    Firm Name
    Fiagon GmbH
    Operator Number
    10046786
    Address
    Neuendorfstr. 23b
    City
    Hennigsdorf
    State
    Brandenburg
    Postal Code
    16761
    Country
    DE

    US Agent

    Business Name
    Fiagon NA
    Contact Name
    Matthew Jones
    Address
    3913 Todd Lane, Suite 101
    City
    Austin
    State
    TX
    ZIP
    78744
    Country
    US
    Email
    [email protected]
    Phone
    512 3838580

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Localizer K-Wire MultiPad RIWOtrack Flexsensor MapperBridge RIWOtrack Navigation System Adapter for Clipsensor RIWOtrack Clipsensor Adapter for Flexsensor RIWOtrack Cube4D Navigation Sensor Flexarm

    Establishment Types

    Manufacture Medical Device