BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SpineKure Kyphoplasty System

    Reg #: 3007955117 · FEI: 3007955117 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HANCHANG CO., LTD
    Registration Number
    3007955117
    FEI Number
    3007955117
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #301-204 Bucheon Techno-park, 345, Seokcheon-ro
    City
    Bucheon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K172871

    Owner / Operator

    Firm Name
    HANCHANG Co., Ltd
    Operator Number
    10057970
    Address
    #301-204 Bucheon Techno-park, 345, Seokcheon-ro
    City
    Bucheon-si
    State
    Gyeonggi
    Postal Code
    14501
    Country
    KR

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN
    Arthroscope HRX

    Proprietary Names

    SpineKure Kyphoplasty System

    Establishment Types

    Manufacture Medical Device