BEUDAMED
    FDA Registration Active 🇫🇷 France

    ECENTIAL ROBOTICS

    Reg #: 3021060474 · FEI: 3021060474 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ECENTIAL ROBOTICS
    Registration Number
    3021060474
    FEI Number
    3021060474
    Status
    Active
    Expiry Year
    2026
    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
    K231886

    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
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO

    Proprietary Names

    A40047 - Fixation Screw A40043 - 3.5 mm Hex Head Screwdriver A40046 - CoBot, Drill Guide - Sleeve A40041 - CoBot, Drill Bit A40059 - Robotic, Tool Holder - Tracker A40045 - CoBot, Spine Instruments Tray A40044 - CoBot, Tool Holder A40042 - CoBot, Drill Guide - Cortical Tip I00019 - CoBot A01039 - Patient Tracker SPX1 I01014 - Op.n Core A00075 - Tracker fixation screw A00066 - Op.n Tracker D I00026 - Op.n Camera A00067 - Navigation Instrument tray I01015 - Op.n Core Power Cord L60018 - Op.n ChoiceSpine App A00065 - Op.n Tracker C I01018 - Op.n Core HDMI cable L60017 - Op.n Perla TL Nav Software A00064 - Op.n Tracker B I01016 - Op.n Core ethernet cable A00063 - Op.n Tracker A A01021 - Broach Set SPX1 A01018 - 3D Imaging Set SPX1

    Establishment Types

    Manufacture Medical Device