BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN

    Reg #: 3013055499 · FEI: 3013055499 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Biomet Global Supply Chain Center B.V.
    Registration Number
    3013055499
    FEI Number
    3013055499
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4836 LD Breda
    City
    Hazeldonk Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K033489

    Owner / Operator

    Firm Name
    ZIMMER GMBH
    Operator Number
    9064978
    Address
    Zahlerweg 4
    City
    Zug
    State
    CH-ZG
    Postal Code
    6300
    Country
    CH

    US Agent

    Business Name
    Zimmer Biomet
    Contact Name
    Holly Seppanen
    Address
    1800 West Center Street
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    952 8470494

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH

    Proprietary Names

    AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device