BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Eclipse Implants

    Reg #: 3000258338 · FEI: 3000258338 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GB IMPLANTAT TECHNOLOGIE GMBH
    Registration Number
    3000258338
    FEI Number
    3000258338
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gesundheitscampus-Sud 5,
    City
    Bochum North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K183194

    Owner / Operator

    Firm Name
    gb Implantat Technologie GmbH
    Operator Number
    10046279
    Address
    Gesundheitscampus-Sud 5,
    City
    Bochum
    State
    North Rhine-Westphalia
    Postal Code
    45145
    Country
    DE
    Correspondent
    Andreas Piotrowski

    US Agent

    Business Name
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    202 8411075

    Products

    Device Name Product Code
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ

    Proprietary Names

    Eclipse Implants

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)