BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    UNITED U2 Hip System

    Reg #: 9681642 · FEI: 1000395711 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    UNITED ORTHOPEDIC CORP.
    Registration Number
    9681642
    FEI Number
    1000395711
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 16, Luke 1st Rd. Luzhu Dist.,
    City
    Kaohsiung
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K111546

    Owner / Operator

    Firm Name
    UNITED ORTHOPEDIC CORPORATION
    Operator Number
    9025838
    Address
    57 Park Ave. 2, Science Park
    City
    Hsinchu
    State
    TW-HSQ
    Postal Code
    TW NOTA300
    Country
    TW

    US Agent

    Business Name
    UOC USA INC.
    Contact Name
    Calvin Lin
    Address
    15251 Alton Parkway, Suite 100
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3283366

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    UNITED U2 Hip System

    Establishment Types

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