BEUDAMED
    FDA Registration Active 🇫🇷 France

    A01020 - Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125 mm

    Reg #: 3021060474 · FEI: 3021060474 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    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
    K221028

    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

    A01020 - Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125 mm A01028 - Navigated Targeting Needle SPX1, Trocar Tip - 11G, 125 mm A01029 - Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm A01019 - Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mm L00016 - 3DSRW Software I00019 - CoBot A01039 - Patient Tracker SPX1

    Establishment Types

    Manufacture Medical Device