BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Thoracolumbosacral pedicle screw system

    Reg #: 3011187779 · FEI: 3011187779 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT
    Registration Number
    3011187779
    FEI Number
    3011187779
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.9 Jingke Road, Nantun District
    City
    Taichung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K180475

    Owner / Operator

    Firm Name
    INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT
    Operator Number
    10046565
    Address
    No.9 Jingke Road, Nantun District
    City
    Taichung City
    State
    TW-TXG
    Postal Code
    40852
    Country
    TW

    US Agent

    Business Name
    Qualtech Consulting LLC
    Contact Name
    Chi-Feng Chang
    Address
    532 Arboles Street
    City
    Monterey Park
    State
    CA
    ZIP
    91754
    Country
    US
    Email
    [email protected]
    Phone
    626 3455899

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Thoracolumbosacral pedicle screw system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)