BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Osteotomy Truss System (OTS)

    Reg #: 3011127597 · FEI: 3011127597 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    4WEB EU B.V.
    Registration Number
    3011127597
    FEI Number
    3011127597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industrieweg 13b
    City
    Assendelft Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K220463

    Owner / Operator

    Firm Name
    4WEB, INC
    Operator Number
    10037722
    Address
    2801 Network Blvd., Suite 620
    City
    Frisco
    State
    TX
    Postal Code
    75034
    Country
    US
    Correspondent
    John J Oldham

    US Agent

    Business Name
    4WEB, INC
    Contact Name
    John Oldham
    Address
    2801 Network Blvd Suite 620
    City
    Frisco
    State
    TX
    ZIP
    75034
    Country
    US
    Email
    [email protected]
    Phone
    214 9983892

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    Osteotomy Truss System (OTS)

    Establishment Types

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