BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    UNITY Sacroiliac Joint Fixation System

    Reg #: 3008526708 · FEI: 3008526708 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Organ Eco Tech
    Registration Number
    3008526708
    FEI Number
    3008526708
    Status
    Active
    Expiry Year
    2025
    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
    K173201

    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
    Natalie Yang

    US Agent

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

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR

    Proprietary Names

    UNITY Sacroiliac Joint Fixation System

    Establishment Types

    Manufacture Medical Device