BEUDAMED
    FDA Registration Active 🇨🇳 China

    Modification to Bioplate Rigid Fixation System

    Reg #: 3011423165 · FEI: 3011423165 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3011423165
    FEI Number
    3011423165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1451, 1st Biyuan Road, High-tech District,
    City
    Xi'an Shaanxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K023810

    Owner / Operator

    Firm Name
    Kontour (Xi'an) Medical Technology Co., Ltd.
    Operator Number
    10062728
    Address
    No.1451, 1st Biyuan Road, High-tech District,
    City
    Xi'an
    State
    Shaanxi
    Postal Code
    710065
    Country
    CN
    Correspondent
    rongrong cong

    Products

    Device Name Product Code
    Plate, Bone JEY

    Proprietary Names

    Modification to Bioplate Rigid Fixation System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)