BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    X-SERIES BI-METRIC HIP FEMORAL COMPONENTS

    Reg #: 3012725451 · FEI: 3012725451 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Zimmer Biomet G.K.
    Registration Number
    3012725451
    FEI Number
    3012725451
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6-15 Shinmachi
    City
    Hiratsuka Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K020580

    Owner / Operator

    Firm Name
    Zimmer Biomet APAC DFE
    Operator Number
    10056128
    Address
    Zimmer Biomet Shanghai
    City
    Shanghai
    State
    CN-SH
    Postal Code
    200051
    Country
    CN

    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, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    X-SERIES BI-METRIC HIP FEMORAL COMPONENTS

    Establishment Types

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