BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    IMEDICOM CO., LTD.

    Reg #: 3009599228 · FEI: 3009599228 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    47
    Establishment Types
    2
    Classifications
    17

    Registration Details

    Registration Name
    IMEDICOM CO., LTD.
    Registration Number
    3009599228
    FEI Number
    3009599228
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #612, #709, #713, #804, #809, #815, 172, LS-ro
    City
    Gunpo-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K103433

    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
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Tray, Surgical, Instrument FSM
    Cement, Bone, Vertebroplasty NDN
    Forceps, General & Plastic Surgery GEN
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Arthroscope HRX
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Motor, Surgical Instrument, Ac-Powered GEY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Orthopedic Manual Surgical Instrument LXH
    Burr, Orthopedic HTT
    Motor, Surgical Instrument, Pneumatic Powered GET
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Tamp HXG
    Catheter, Conduction, Anesthetic BSO
    Mixer, Cement, For Clinical Use JDZ

    Proprietary Names

    EZImpactor Xtrat-P EZX Blade EZX Brasseler EZX Brasseler EZX Blade EZX Tray, Brasseler EZX Tray MVX Plus SPINAUT-F MEDINAUT Flex MEDINAUT-X B-Two Inflatable bone expander system syringe B-Two Vertebral access system B-Two Inflatable bone expander system balloon catheter B-Two Vertebral Balloon Expand® Kyphoplasty System MEDINAUT-I MEDINAUT Kyphoplasty System MEDINAUT-Ix MEDINAUT-V SYNTH™ VRT MVX US MEDINAUT MAX MEDINAUT MAX Pro ZAGUAR SPINAUT-S SPINAUT-V SPINAUT-I SPINAUT-P B-Two Inflatable bone expander system baloon catheter SYNTH™ STANDARD SYNTH™ BES SYNTH™ CDS SPINAUT-Ix(various models) MEDINAUT-Ix(various models) IMEDICOM HIGH SPEED BLADE LEOPARD (various models) IMEDICOM SAW BLADE MEDINAUT Plus SYNTH™ PLUS BILATERAL SteriSpine VA SYNTH™ PLUS EPINAUT MCX Plus (various models) MCX (various models) MCX Light (various models) Mixing Bowl SPINAUT-E

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device