BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Midshaft and Distal Clavicle plates

    Reg #: 3004638532 · FEI: 3004638532 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    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
    K142306

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    Midshaft and Distal Clavicle plates Lateral Humerus plate Olecranon plate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)