BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Joimax® Intracs® System

    Reg #: 3010020902 · FEI: 3010020902 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ERGOSURG
    Registration Number
    3010020902
    FEI Number
    3010020902
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gleissenweg 1
    City
    Ismaning Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K192663

    Owner / Operator

    Firm Name
    Ergosurg
    Operator Number
    10056539
    Address
    Gleissenweg 1
    City
    Ismaning
    State
    Bavaria
    Postal Code
    85737
    Country
    DE

    US Agent

    Business Name
    GSM Services
    Contact Name
    Gary Mocnik
    Address
    49 Coastal Oak
    City
    Aliso Viejo
    State
    CA
    ZIP
    92656
    Country
    US
    Email
    [email protected]
    Phone
    949 4330413

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Joimax® Intracs® System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)