BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    VERTEX® Reconstruction System

    Reg #: 3002807561 · FEI: 3002807561 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC B.V. (EOC)
    Registration Number
    3002807561
    FEI Number
    3002807561
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EARL BAKKENSTRAAT 10
    City
    HEERLEN Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K091813

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    Medtronic Sofamor Danek USA, Inc. (Pyramid Place)
    Contact Name
    Michelle Obenauer
    Address
    1800 Pyramid Place
    City
    Memphis
    State
    TN
    ZIP
    38132
    Country
    US
    Email
    [email protected]
    Phone
    901 3992117

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    VERTEX® Reconstruction System SOVEREIGN Spinal System CD HORIZON® Spinal System

    Establishment Types

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