BEUDAMED
    FDA Registration Active 🇨🇳 China

    Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology

    Reg #: 3005677016 · FEI: 3005677016 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Medtronic (Changzhou) Medical Devices Technology Co., Ltd
    Registration Number
    3005677016
    FEI Number
    3005677016
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building #3, 11 ChangJiang North Road, Xinbei District
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K214010

    Owner / Operator

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

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology

    Establishment Types

    Manufacture Medical Device