BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    B-Two Inflatable bone expander system syringe

    Reg #: 3009599228 · FEI: 3009599228 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IMEDICOM CO., LTD.
    Registration Number
    3009599228
    FEI Number
    3009599228
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #612, #709, #713, #804, #809, #815, 172, LS-ro
    City
    Gunpo-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K153296

    Owner / Operator

    Firm Name
    IMEDICOM Co., Ltd.
    Operator Number
    10041241
    Address
    #612, 172, LS-ro
    City
    Gunpo-si
    State
    Gyeonggi
    Postal Code
    435824
    Country
    KR
    Correspondent
    Don Soo Joo

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

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

    Proprietary Names

    B-Two Inflatable bone expander system syringe MEDINAUT-X B-Two Vertebral access system B-Two Inflatable bone expander system baloon catheter MEDINAUT-I MEDINAUT-Ix B-Two Vertebral Balloon Expand® Kyphoplasty System MEDINAUT Kyphoplasty System SYNTH™ CDS SYNTH™ STANDARD SYNTH™ BES

    Establishment Types

    Manufacture Medical Device