BEUDAMED
    FDA Registration Active 🇫🇷 France

    ExactechGPS® Total Ankle Application

    Reg #: 3008027912 · FEI: 3008027912 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BLUE ORTHO
    Registration Number
    3008027912
    FEI Number
    3008027912
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22 Chemin du Vieux Chene
    City
    Meylan Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K232521

    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

    US Agent

    Business Name
    Exactech Inc
    Contact Name
    Matt Collins
    Address
    2320 NW 66th Ct
    City
    Gainesville
    State
    FL
    ZIP
    32653
    Country
    US
    Email
    [email protected]
    Phone
    352 3771140

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    ExactechGPS® Total Ankle Application

    Establishment Types

    Manufacture Medical Device