BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ARIX Hand SYSTEM

    Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    305
    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
    K131566

    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 SYSTEM SO-23-CS-028L SO-23-CH-017 SO-23-CH-025 SO-23-CS-013L CC2326 CCH2323 VERUM System Bone Screw SO-23-CS-015L SO-23-CH-019 CC2328 CCH2324-L Summa Orthopaedics System Bone Screw SO-23-CH-017L SO-23-CH-026 SO-23-CH-012 SO-23-CH-030L CC2314-L CCH2316-L CC2317-L CCH2318 SO-23-CS-026 SO-23-CH-015 SO-23-CH-023 CC2316-L CCH2317-L SO-23-CS-020 SO-23-CH-019L SO-23-CS-026L SO-23-CH-016 SO-23-CH-024 CCH2314 CCH2335-L SO-23-CH-018 SO-23-CH-026L SO-23-CS-010L CC2322 SO-23-CH-020 CC2319-L CC2335-L SO-23-CS-011L CCH2319 CCH2315 CC2309-L CC2322-L CC2310-L CC2324 CCH2322 SUMMA 2.3 Cannulated Screws System SO-23-CH-010 SO-23-CH-029 SO-23-CS-028 SO-23-CH-016L SO-23-CH-024L SO-23-CS-009L SO-23-CS-022L SO-23-CH-021 SO-23-CS-014L SO-23-CH-018L CC2318-L CC2335 CCH2318-L CCH2311 CCH2320-L CCH2330 SO-23-CS-017L SO-23-CS-030L CC2326-L CCH2324 CCH2316 SO-23-CH-011 SO-23-CH-030 SO-23-CS-019L SO-23-CS-035L SO-23-CH-028 SO-23-CS-024L SO-23-CH-022L Summa Orthopaedics Hand System Bone Plate CC2330 CCH2326 VERUM System SO-23-CH-009 SO-23-CH-028L CCH2327 CCH2313 CCH2335 SO-23-CH-014 SO-23-CH-035L CCH2328 SO-23-CS-012L CC2313-L SO-23-CS-016L SO-23-CS-030 SO-23-CS-020L CC2311-L CC2324-L CCH2322-L VERUM Hand System Bone Plate SO-23-CS-022 SO-23-CH-020L CC2328-L CCH2325 CC2320 CCH2309 CCH2319-L CCH2328-L CC2315-L CCH2317 SO-23-CS-024 SO-23-CH-022 CC2320-L CCH2310 CCH2320 CCH2329 SO-23-CS-018L SO-23-CS-035 SO-23-CH-027 CCH2312 CCH2321 CCH2330-L CC2330-L CCH2326-L SO-23-CH-013 SO-23-CH-035 CC2312-L IN15-HC-007 IN15-HC-014 IN23-CH-030 IN30-CS-022 IN30-CS-040L IN23-CH-020L IN23-CS-022L IN30-CH-022 IN30-CH-040L IN23-CH-015 IN23-CH-023 IN23-CH-035L IN30-CH-030L IN30-CS-017 IN30-CS-030L IN23-CS-028 IN30-CH-024L IN30-CS-008 IN30-CS-024L IN15-HC-011 IN23-CH-010 IN23-CH-028L IN15-HC-018 IN30-CH-018L IN30-CS-021 IN30-CS-028 IN30-CS-038L IN23-CH-012 IN23-CH-021 IN30-CH-015 IN30-CH-029 IN30-CS-015L IN30-CS-029 IN23-CS-012L IN23-FC-010 IN30-CH-019 IN23-CH-018L IN23-CS-019L IN30-CH-010 IN30-CH-020 IN30-CH-026L IN30-CH-036L IN23-CH-011 IN23-CH-029 IN30-CH-014 IN30-CH-028L IN30-CS-015 IN30-CS-028L IN30-CH-021L IN30-CS-021L IN30-CS-040 IN15-HC-006 IN23-CS-026L IN30-CH-024 IN30-CH-050L IN30-CS-024 IN23-CH-019 IN23-CS-020 IN30-CH-020L IN30-CH-038 IN15-HC-008 IN15-HC-016 IN23-CH-027 IN23-CS-035L IN30-CH-011 IN30-CH-027 IN30-CS-013 IN30-CS-027 IN23-CH-019L IN23-FC-006 IN30-CH-012 IN30-CH-027L IN30-CS-014 IN30-CS-027L IN15-HC-020 IN23-CH-014 IN23-CH-035 IN30-CH-030 IN30-CS-016L IN30-CS-030 IN23-CS-020L IN30-CH-021 IN30-CH-038L IN23-CS-013L IN30-CH-019L IN30-CS-036 IN23-CH-020 IN23-CS-022 IN30-CH-013 IN30-CH-028 IN30-CH-040 IN30-CS-014L IN23-CS-014L IN30-CS-020 IN30-CS-036L IN23-CH-016L IN23-CS-010L IN30-CH-018 IN30-CS-018 IN30-CS-032L IN23-CH-013 IN23-CH-030L IN30-CS-022L IN30-CS-045 INLET System Bone Screw IN15-HC-010 IN23-CS-024L IN23-CH-009 IN23-CH-028 IN30-CH-023 IN30-CH-045L IN30-CS-045L IN23-CH-026L IN23-CS-018L IN23-CS-035 IN30-CS-020L IN30-CS-038 IN30-CH-036 IN30-CS-012 IN30-CS-019L IN30-CS-026L IN23-CH-024 IN15-HC-013 IN30-CH-032 IN23-CH-016 IN30-CS-017L IN23-CS-009L IN30-CS-032 IN23-CS-024 IN30-CH-017L IN30-CS-050L IN30-CH-022L IN30-CH-045 IN15-HC-012 IN23-CH-017L IN23-CH-025 IN23-CS-030 IN23-CH-022 IN23-CH-026 IN23-CS-017L IN23-CH-018 IN23-CS-030L IN30-CH-025L IN30-CS-010 IN30-CS-025L IN30-CH-016 IN30-CH-029L IN30-CH-026 IN30-CS-011 IN30-CS-016 IN30-CH-034L IN30-CS-026 IN30-CS-023 IN30-CS-029L IN30-CS-019 IN30-CS-034L IN15-HC-009 IN18-HC-010 IN23-CH-022L IN23-CS-026 IN23-CH-024L IN23-CS-015L IN23-CS-028L IN30-CH-016L IN30-CH-023L IN30-CH-050 IN30-CS-023L IN30-CH-025 IN30-CH-032L IN30-CS-009 IN30-CS-025 IN18-HC-006 IN23-CH-017 IN23-CS-011L IN23-CS-016L IN30-CH-034 IN30-CS-018L IN30-CS-034 IN30-CH-017 IN30-CS-050

    Establishment Types

    Manufacture Medical Device