BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    NILE™ Alternative Fixation System

    Reg #: 3004638532 · FEI: 3004638532 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PURACON GMBH
    Registration Number
    3004638532
    FEI Number
    3004638532
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Isarstrasse 1
    City
    Rosenheim Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K143350

    Owner / Operator

    Firm Name
    puracon GmbH
    Operator Number
    10028435
    Address
    Isarstrasse 1
    City
    Rosenheim
    State
    Bavaria
    Postal Code
    D-83026
    Country
    DE

    Products

    Device Name Product Code
    Bone Fixation Cerclage, Sublaminar OWI

    Proprietary Names

    NILE™ Alternative Fixation System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)