BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Organ Eco Tech

    Reg #: 3008526708 · FEI: 3008526708 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    Organ Eco Tech
    Registration Number
    3008526708
    FEI Number
    3008526708
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #103-105 Megacenter, SKn technopark 124, Sagimakgol-ro, Jungwon-gu
    City
    Seongnam-Si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K162220

    Owner / Operator

    Firm Name
    Organ Eco Tech Co., Ltd.
    Operator Number
    10033497
    Address
    #204, Megacenter, Bando Ivy Valley, 686, Cheonggyesan-ro
    City
    Seoungnam
    State
    Gyeonggi
    Postal Code
    13207
    Country
    KR
    Correspondent
    Eunbi Jo

    US Agent

    Business Name
    Dio Medical Corporation
    Contact Name
    Eunbi Jo
    Address
    2100 Campus Lane, Suite 100
    City
    Audubon
    State
    PA
    ZIP
    19403
    Country
    US
    Email
    [email protected]
    Phone
    877 3945403 ext. 102

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Spinous Process Plate PEK
    Thoracolumbosacral Pedicle Screw System NKB
    Sacroiliac Joint Fixation OUR
    System, Facet Screw Spinal Device MRW
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    IVA INTERBODY FUSION CAGE SYSTEM Fortis & Hana Anterior Cervical Plate System Huvex Interspinous Fixation System Rex Anterior Cervical Plate System Rexious CoCr rods IVA Intervertebral Titanium Fusion Cage System UNITY Sacroiliac Joint Fixation System FaSet Fixation System REXIOUS HOOK FIXATION SYSTEMS Balteum" Lumbar Plate System VICEROY Instrument AEON-C" Stand Alone System

    Establishment Types

    Manufacture Medical Device