BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SO-35L-SO-L14-T

    Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    138
    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
    K193616

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    SO-35L-SO-L14-T SO-35L-SO-L18-T SO-35L-SO-L10-T SO-35L-SO-L22-T SO-35L-SO-L12-T SO-35-SO-L45-T PRO-10214 ARIX Ankle System Prometheus System Bone Screw PRO-10215 112-140, Tray PRO-90104 PRO-10229 112-146-05 PRO-10216 PRO-10211 PRO-10212 INLET System Surgical Instrument PRO-10227 112-146 PRO-10223 PRO-10226 112-087, Tray PRO-10213 PRO-10210 PRO-10228 PRO-10222 PRO-10225 IN35-SO-L36-T IN35-SO-L32-T PRO-10224 PRO-10209 IN35L-SO-L28-TA IN35L-SO-L32-TA IN35V-DLF2-006-R IN35L-SO-L30-TA IN35-SO-L38-T IN35-SO-L48-T IN35-SO-L28-T IN112-146 IN112-136-1 IN35-SO-L70-T IN35V-DLF2-008-L IN35L-SO-L48-TA IN35-SO-L22-T IN35-SO-L55-T IN35-SO-L60-T IN35V-DLF2-008-R IN35L-SO-L12-TA IN35-SO-L45-T IN35-SO-L10-T IN35-SO-L40-T IN35L-SO-L10-TA IN35L-SO-L14-TA IN35L-SO-L18-TA IN35-SO-L46-T IN35L-SO-L22-TA IN35L-SO-L26-TA IN35-SO-L12-T INLET Distal Fibula2 System Bone Plate IN35V-DLF2-003-R IN35L-SO-L34-TA IN35L-SO-L38-TA IN35L-SO-L42-TA IN35L-SO-L45-TA IN35-SO-L50-T IN35L-SO-L36-TA IN35L-SO-L44-TA IN35-SO-L30-T IN35-SO-L52-T IN35V-DLF2-005-R IN35V-DLF2-005-L IN35-SO-L24-T IN35-SO-L26-T IN35V-DLF2-003-L IN35L-SO-L20-TA IN35L-SO-L24-TA IN35V-DLF2-004-L IN35-SO-L16-T IN35V-DLF2-007-R IN35L-SO-L16-TA INLET System Bone Screw IN35V-DLF2-006-L IN35-SO-L20-T IN35V-DLF2-004-R IN35-SO-L34-T IN35-SO-L42-T IN35L-SO-L40-TA IN35L-SO-L46-TA IN35L-SO-L50-TA IN35-SO-L44-T IN35-SO-L56-T IN35-SO-L65-T SO-35V-DLF2-003-L SO-35L-SO-L22-TA SO-35V-DLF2-007-R SO-35L-SO-L18-TA IN35-SO-L14-T IN35V-DLF2-007-L IN35-SO-L18-T IN112-136-3 SO-35V-DLF2-006-L SO-35V-DLF2-005-R IN112-136-2 SO-35V-DLF2-005-L SO-35-SO-L20-T SO-35L-SO-L16-TA SO-35-SO-L50-T SO-35-SO-L12-T SO-35-SO-L14-T SO-35V-DLF2-008-L SO-35V-DLF2-003-R SO-35V-DLF2-004-R SO-35L-SO-L10-TA SO-35V-DLF2-008-R SO-35L-SO-L20-TA SO-35V-DLF2-006-R SO-35-SO-L70-T SO-35-SO-L10-T SO-35-SO-L22-T SO-35V-DLF2-007-L SO-35-SO-L65-T SO-35-SO-L18-T SO-35-SO-L60-T SO-35-SO-L55-T SO-35-SO-L16-T Summa Orthopaedics Ankle System Bone Plate SO-35V-DLF2-004-L SO-35L-SO-L24-TA SO-35-SO-L24-T SO-112-146-05 SO-35L-SO-L14-TA SO-112-146 SO-35L-SO-L12-TA SO-35L-SO-L45-TA SO-35L-SO-L20-T SO-35L-SO-L24-T SO-35L-SO-L16-T

    Establishment Types

    Manufacture Medical Device