BEUDAMED
    FDA Registration Active 🇫🇷 France

    BLUE ORTHO

    Reg #: 3008027912 · FEI: 3008027912 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    BLUE ORTHO
    Registration Number
    3008027912
    FEI Number
    3008027912
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22 Chemin du Vieux Chene
    City
    Meylan Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K100742

    Owner / Operator

    Firm Name
    BLUE ORTHO
    Operator Number
    10037278
    Address
    22 Chemin du Vieux Chene
    City
    Meylan
    State
    Isere
    Postal Code
    38240
    Country
    FR
    Correspondent
    Matthieu COIC

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW
    Orthopedic Stereotaxic Instrument OLO
    System, Image Processing, Radiological LLZ
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    Blue Ortho ExactechGPS® System ExactechGPS® Total Shoulder Application ExactechGPS System ExactechGPS Total Shoulder Application ExactechGPS® Total Ankle Application

    Establishment Types

    Manufacture Medical Device