BEUDAMED
    FDA Registration Active 🇫🇷 France

    ROMEO 2

    Reg #: 3037407500 · FEI: 3037407500 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALPES CN SAS
    Registration Number
    3037407500
    FEI Number
    3037407500
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    356 Rue de la Tour
    City
    Reignier-Esery Haute-Savoie
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K141835

    Owner / Operator

    Firm Name
    SPINEART SA
    Operator Number
    10028947
    Address
    Chemin du Pre-Fleuri 3
    City
    Plan-les-Ouates
    State
    Geneve
    Postal Code
    1228
    Country
    CH
    Correspondent
    Max LOK

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    ROMEO 2

    Establishment Types

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