BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ARIX Ankle Fibula Hook Plate System

    Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JEIL MEDICAL CORPORATION
    Registration Number
    3014937101
    FEI Number
    3014937101
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    380, Beoman-ro
    City
    Siheung-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K170979

    Owner / Operator

    Firm Name
    JEIL MEDICAL CORPORATION
    Operator Number
    9053245
    Address
    702,703,704,705,706,707,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    08378
    Country
    KR
    Correspondent
    Jinwoo Kim

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    ARIX Ankle Fibula Hook Plate System SUMMA Hook Fibula System SO-35V-DLFH-003 VERUM System Bone Screw SO-35V-DLFH-004 VA2030 Summa Orthopaedics Ankle Fibula Hook Plate System Bone Plate VA2040 Summa Orthopaedics System Bone Screw VERUM Ankle Fibula Hook System VERUM Ankle Fibula Hook System Bone Plate PRO-10061 PRO-10026 Prometheus Ankle Fibula Hook Plate System Bone Plate

    Establishment Types

    Manufacture Medical Device