BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ARIX Wrist System

    Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    116
    Establishment Types
    1
    Classifications
    2

    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
    K151468

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    ARIX Wrist System SO-25-DVRA-311-R SUMMA Distal Radius System PR2522 VERUM WRIST SO-16132516 SO-16132520 SO-25-HF-024 PR2530 SO-25-DVRA-311-L PR2512-L PR2516 PR1070 PR2524 PR2518-L PR1100 SO-25-DVRA-209-R PR2516-L PR1090 PR2510 PR1040 SO-25-HF-018 SO-25-DVRA-211-L SO-16132530 SO-16132508 VERUM Wrist System Bone Plate PR1120 PR0910 PR1010 SO-25-HF-020 SO-25-DVRA-309-R PR2518 SO-16132510 SO-16132512 PR2526 PR1020 PR1030 Summa Orthopaedics Wrist System Bone Plate SO-25-DVRA-111-R PR2530-L SO-16132528 PR2520-L PR1110 SO-25-HF-022 SO-25-DVRA-309-L SO-25-HF-012 PRO-10384 PR0913 SO-16132518 PR2520 PR2528 SO-16132524 SO-25-HF-028 VERUM System Bone Screw PR2522-L SO-25-DVRA-111-L SO-25-HF-016 SO-25-DVRA-211-R SO-25-DVRA-109-R PR2508 PR2526-L SO-25-DVRA-109-L PR2528-L PR2510-L PR2514 PR1060 SO-16132514 SO-16132522 SO-25-HF-026 SO-25-HF-008 PR0911 SO-25-HF-010 PR2514-L PR1080 PR0912 SO-25-HF-014 Summa Orthopaedics System Bone Screw PR0914 SO-16132526 SO-25-HF-030 PRO-10385 PR2524-L SO-25-DVRA-209-L PR2508-L PR2512 PR1050 PRO-10378 PRO-10388 PRO-10386 PRO-10382 PRO-10381 PRO-10389 PRO-10390 Prometheus Wrist System Bone Plate IN25-DVRA-109-R PRO-10392 PRO-10387 PRO-10383 PRO-10394 PRO-10377 PRO-10380 PRO-10391 PRO-10393 IN25-DVRA-111-L IN25-DVRA-309-R IN25-DVRA-209-R PRO-10379 IN25-DVRA-111-R IN25-DVRA-211-L INLET Distal Radius 2 System Bone Plate IN25-DVRA-209-L IN25-DVRA-211-R IN25-DVRA-109-L IN25-DVRA-311-R IN25-DVRA-309-L IN25-DVRA-311-L

    Establishment Types

    Manufacture Medical Device