BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Wiltrom Spinal Fixation System

    Reg #: 3011964577 · FEI: 3011964577 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    WILTROM CORPORATION LIMITED
    Registration Number
    3011964577
    FEI Number
    3011964577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 F., No. 26, Sec. 2, Shengyi Rd.
    City
    Zhubei City Hsinchu
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K202894

    Owner / Operator

    Firm Name
    Wiltrom Corporation Limited
    Operator Number
    10042632
    Address
    1 F., NO. 26, SEC. 2, SHENGYI RD.
    City
    ZHUBEI CITY
    State
    Hsinchu
    Postal Code
    30261
    Country
    TW
    Correspondent
    Freda Lin

    US Agent

    Business Name
    Wiltrom Inc.
    Contact Name
    Brad Lin
    Address
    2880 ZANKER ROAD, SUITE 103
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US
    Email
    [email protected]
    Phone
    415 8649171

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Wiltrom Spinal Fixation System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device