BEUDAMED
    FDA Registration Active 🇨🇳 China

    FRAGMENT PLATE SYSTEM

    Reg #: 3007923096 · FEI: 3007923096 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Changzhou Biomet Medical Devices Co., Ltd.
    Registration Number
    3007923096
    FEI Number
    3007923096
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 235 Chuangxin Road, EPZ Xinbei District
    City
    Changzhou City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K061748

    Owner / Operator

    Firm Name
    Biomet, Inc.
    Operator Number
    1825034
    Address
    56 East Bell Dr., PO Box 587
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    FRAGMENT PLATE SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)