BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Mazor X System (Mazor X Stealth Edition)

    Reg #: 3005075696 · FEI: 3005075696 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MAZOR ROBOTICS LTD.
    Registration Number
    3005075696
    FEI Number
    3005075696
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 HaEshel Street (Building C), Caesarea Business Park
    City
    Caesarea Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K230064

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    Medtronic
    Contact Name
    Alison Webster
    Address
    1800 Pyramid Place
    City
    Memphis
    State
    TN
    ZIP
    38132
    Country
    US
    Email
    [email protected]
    Phone
    901 3992384

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Mazor X System (Mazor X Stealth Edition)

    Establishment Types

    Manufacture Medical Device