BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ARIX Ankle System

    Reg #: 3004049923 · FEI: 3004049923 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    165
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JEIL MEDICAL CORPORATION
    Registration Number
    3004049923
    FEI Number
    3004049923
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    702,703,704,705,706,707,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu,
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K152158

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    ARIX Ankle System VERUM ANKLE SO-35-DLST-003 PA3540 PA1080 SO-35-FC-010 PA3532-L PA0914 SO-35-FC-014 SO-35-FC-065 PA3540-L SO-35L-HF-032 SO-35-DLST-008 PA1120 SO-35L-HF-014 SO-35-DLST-004 PA1050 PA3545 PA1090 SO-35L-HF-020 Summa Orthopaedics Ankle Fibula Hook Plate System Bone Plate SO-35-FC-020 SO-35L-HF-018 SO-35-DLFI-003-R PA3520-L PA1020 SO-35-FC-050 SO-35-DLFI-006-R PA3528 SO-35L-HF-024 SO-35-FC-024 SO-35L-HF-036 PA1130 PA0910 SO-35-FC-055 SO-35-DLFI-007-R PA3532 SO-35-DLST-005 SO-35L-HF-040 SO-35L-HF-045 PA3550 PA1100 PA1140 PA0911 PA1150 PA0912 Summa Orthopaedics System Bone Screw VERUM Ankle System Bone Plate VERUM System Bone Screw SUMMA Fibula System SO-35-DLFI-007-L PA3516-L PA3516 PA3570 SO-35L-HF-022 SO-35-FC-022 SO-35-DLFI-008-R SO-35-FC-036 PRO-10334 PRO-10362 PA3520 PA3536 PA1070 SO-35-FC-012 SO-35-FC-060 PA3536-L PA0915 SO-35-DLST-006 PA1110 SO-35-FC-018 SO-35-DLFI-003-L PA3550-L SO-35-DLFI-008-L SO-35-FC-045 SO-35-DLFI-005-R SO-35-DLFI-005-L PA3518-L PA1010 PA3512-L PA3512 PA3560 PA3524 SO-35-DLFI-006-L SO-35-DLST-010 PA3514-L PA3514 PA3565 SO-35L-HF-012 PA3524-L PA1040 PA1180 PRO-10320 PRO-10359 SO-35L-HF-050 PRO-10357 PA3528-L PA1160 PA0913 SO-35-FC-016 SO-35-FC-070 SO-35L-HF-028 SO-35-FC-028 PA3545-L SO-35L-HF-016 SO-35-FC-032 PA3518 PA1060 SO-35-FC-040 SO-35-DLFI-004-R PA3522 SO-35-DLFI-004-L PRO-10335 PRO-10363 PA3510-L PA3510 PA3555 SO-35L-HF-010 PRO-10348 PA3522-L PA1030 PA1170 PRO-10347 PRO-10328 PRO-10342 PRO-10345 PRO-10338 PRO-10352 PRO-10366 PRO-10355 Prometheus System Bone Screw PRO-10336 PRO-10350 PRO-10364 PRO-10318 PRO-10332 PRO-10360 PRO-10317 PRO-10331 PRO-10339 PRO-10353 PRO-10354 PRO-10349 PRO-10358 PRO-10337 PRO-10351 PRO-10365 PRO-10326 PRO-10340 PRO-10322 PRO-10325 PRO-10356 Prometheus Ankle System Bone Plate PRO-10319 PRO-10333 PRO-10361 PRO-10330 PRO-10327 PRO-10341 PRO-10321 PRO-10324 PRO-10346 PRO-10344 PRO-10323 PRO-10329 PRO-10343

    Establishment Types

    Manufacture Medical Device