BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AGILON® XO Shoulder Replacement System

    Reg #: 3012523063 · FEI: 3012523063 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    implantcast GmbH
    Registration Number
    3012523063
    FEI Number
    3012523063
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lueneburger Schanze 26
    City
    Buxtehude Lower Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K241944

    Owner / Operator

    Firm Name
    implantcast GmbH
    Operator Number
    10054139
    Address
    Lueneburger Schanze 26
    City
    Buxtehude
    State
    Lower Saxony
    Postal Code
    21614
    Country
    DE
    Correspondent
    Juliane Hoeppner

    US Agent

    Business Name
    IMPLANTCAST AMERICA, LLC
    Contact Name
    Andrew Hewes
    Address
    13465 Midway Rd, Ste 310
    City
    Dallas
    State
    TX
    ZIP
    75244
    Country
    US
    Email
    [email protected]
    Phone
    512 7797282

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT

    Proprietary Names

    AGILON® XO Shoulder Replacement System

    Establishment Types

    Manufacture Medical Device