BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ARIX Hand Locking System

    Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    38
    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
    K132876

    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 Hand Locking System VERUM Hand System Bone Plate VERUM Hand VERUM System Bone Screw INH2L-TP-007 IN20-HF-011 IN20L-HF-013 INH2L-LR-006 IN20-HF-008 IN20-HF-016 IN20L-HF-010 IN20L-HF-020 IN20-HF-013 IN20L-HF-016 IN20L-HF-006 IN20-HF-010 IN20L-HF-012 INLET New Hand System Bone Plate IN20-HF-012 IN20L-HF-014 IN20L-HF-018 INH2L-LL-006 INH2L-QD-006 IN20L-HF-007 IN20-HF-007 IN20-HF-014 IN20L-HF-009 INH2L-YP-007 IN20-HF-020 INH2L-YP-006 INH2L-ST-006 IN20-HF-018 IN20-HF-009 IN20L-HF-011 INLET System Bone Screw INH2L-ST-004 IN20-HF-006 IN20L-HF-008

    Establishment Types

    Manufacture Medical Device