BEUDAMED
    FDA Registration Active 🇫🇷 France

    A00067 - Navigation Instrument tray

    Reg #: 3021060474 · FEI: 3021060474 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ECENTIAL ROBOTICS
    Registration Number
    3021060474
    FEI Number
    3021060474
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1
    City
    Gieres Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K242914

    Owner / Operator

    Firm Name
    Ecential Robotics
    Operator Number
    10084446
    Address
    2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1
    City
    Gieres
    State
    Isere
    Postal Code
    38610
    Country
    FR
    Correspondent
    Elodie bouillet

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    A00067 - Navigation Instrument tray I01018 - Op.n Core HDMI cable A00075 - Tracker fixation screw A00066 - Op.n Tracker D I00026 - Op.n Camera A00064 - Op.n Tracker B I01015 - Op.n Core Power Cord I01016 - Op.n Core ethernet cable L60017 - Op.n Perla TL Nav Software L60018 - Op.n ChoiceSpine App I01014 - Op.n Core A00065 - Op.n Tracker C A00063 - Op.n Tracker A

    Establishment Types

    Manufacture Medical Device