BEUDAMED
    FDA Registration Active 🇫🇷 France

    ROMEO LC

    Reg #: 3037407500 · FEI: 3037407500 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    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
    K112108

    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, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    ROMEO LC

    Establishment Types

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