BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SALGINA 2.5mm Wrist Spanning Plate

    Reg #: 3004638532 · FEI: 3004638532 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    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
    K243308

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    SALGINA 2.5mm Wrist Spanning Plate SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Left LEPORELLO 3.5mm Olecranon Plate 7 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Right LEPORELLO 3.5mm Olecranon Plate 7 Hole, Left CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 15 Hole, Left SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Left SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Left SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Right SALGINA 2.5mm Dorsal Distal Radius Plate, 6 Hole, Left CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 15 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Left SALGINA 2.5mm Dorsal Distal Radius Plate, 6 Hole, Right

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)