BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SO-35L-SO-L10-T

    Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    248
    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
    K202912

    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-L10-T SO-35L-SO-L22-T 112-116-5, Tray SO-35-DLTB-006-R SO-40-SA-016-T SO-35L-SO-L40-TA SO-40L-SA-030-TA SO-40L-SA-034-TA IN35-DLTB-003-R SO-35L-SO-L24-TA SO-35-DLTB-008-R SO-40-SA-018-T IN35L-SO-L12-TA SO-35L-SO-L30-TA SO-40L-SA-048-TA SO-35-DLTB-004-L SO-40-SA-024-T SO-40-SA-056-T IN35-SO-L45-T SO-35L-SO-L10-TA SO-35-DMTB-004-R SO-40L-SA-014-TA SO-40-SA-032-T SO-35L-SO-L22-TA SO-35L-SO-L50-TA SO-35-DMTB-004-L SO-40-SA-044-T SO-35L-SO-L20-TA SO-35L-SO-L48-TA SO-35-DMTB-014-R SO-40-SA-042-T SO-35L-SO-L36-TA SO-40L-SA-026-TA SO-40L-SA-060-TA SO-40-SA-030-T SO-35L-SO-L16-TA SO-35L-SO-L44-TA SO-35-DMTB-010-R SO-40-SA-010-T SO-40-SA-038-T SO-35L-SO-L26-TA SO-35-DLTB-010-R SO-40-SA-020-T 112-116-3, Tray INLET Distal Tibia System Bone Plate ARIX Ankle Distal Tibia System IN35-SO-L32-T IN40-SA-016-T IN40-SA-044-T 112-116-2, Tray IN40-SA-012-T SO-35-DLTB-003-R SO-40-SA-012-T 112-116-4, Tray SO-35L-SO-L56-TA SO-40-SA-048-T SO-35L-SO-L32-TA SO-40L-SA-050-TA SO-35-DLTB-006-L SO-35L-SO-L34-TA SO-40L-SA-056-TA SO-40-SA-026-T SO-40-SA-028-T SO-40-SA-060-T IN35-SO-L26-T 112-116-1, Tray IN40L-SA-022-TA IN40L-SA-036-TA IN35-DLTB-006-R IN35-DLTB-004-R IN35-DMTB-004-L IN35L-SO-L56-TA 112-116, Tray IN35-SO-L40-T IN35-SO-L46-T IN35-DLTB-010-L IN35-DMTB-008-R IN35L-SO-L16-TA IN35L-SO-L20-TA IN40-SA-022-T SO-40L-SA-022-TA SO-35L-SO-L52-TA SO-35-DMTB-006-L SO-40-SA-046-T SO-35L-SO-L42-TA SO-40L-SA-032-TA IN35L-SO-L10-TA IN35L-SO-L18-TA SO-35L-SO-L28-TA SO-40L-SA-046-TA IN35-SO-L70-T IN40L-SA-048-TA SO-40L-SA-038-TA IN40L-SA-042-TA SO-35-SO-L60-T SO-35-DLTB-003-L SO-35L-SO-L38-TA SO-40-SA-022-T SO-35-DMTB-008-L SO-40L-SA-028-TA IN40L-SA-060-TA IN112-116 IN40L-SA-032-TA IN40L-SA-046-TA SO-35-DLTB-008-L SO-40L-SA-010-TA SO-35-DLTB-004-R IN40L-SA-018-TA IN40-SA-038-T SO-40L-SA-044-TA SO-40-SA-014-T SO-35-DMTB-014-L SO-40L-SA-036-TA SO-35-SO-L56-T SO-35L-SO-L18-TA SO-35L-SO-L46-TA SO-35-DMTB-012-R SO-40-SA-040-T SO-35L-SO-L14-TA SO-35-DMTB-008-R SO-40L-SA-042-TA SO-40L-SA-018-TA SO-40L-SA-040-TA SO-35-DLTB-010-L SO-40L-SA-012-TA SO-35-DMTB-012-L SO-35-DMTB-010-L SO-40-SA-036-T IN35-DLTB-010-R IN35-DMTB-010-L IN40-SA-040-T IN35-SO-L48-T IN40-SA-026-T SO-35L-SO-L60-TA SO-40-SA-050-T IN35-DLTB-004-L SO-40L-SA-024-TA IN40L-SA-040-TA IN40L-SA-056-TA IN35-DLTB-006-L IN35-DMTB-004-R SO-40L-SA-020-TA IN112-108 INLET System Bone Screw IN35-SO-L34-T IN40L-SA-012-TA SO-35L-SO-L12-TA SO-35-DMTB-006-R SO-40L-SA-016-TA SO-40-SA-034-T IN40-SA-032-T IN35-DMTB-006-R IN35L-SO-L38-TA IN35L-SO-L42-TA IN35L-SO-L45-TA IN35-SO-L50-T IN35-SO-L55-T IN40-SA-014-T IN40-SA-042-T IN35-DMTB-006-L IN35-SO-L18-T IN40-SA-010-T IN35-SO-L36-T IN40-SA-020-T IN40-SA-048-T IN40L-SA-050-TA IN40-SA-024-T IN35L-SO-L28-TA IN35L-SO-L32-TA IN35L-SO-L40-TA IN40L-SA-038-TA INLET System Surgical Instrument IN35-DLTB-003-L IN35L-SO-L46-TA IN35L-SO-L50-TA IN35-SO-L44-T IN35-SO-L56-T IN35-SO-L65-T IN35-SO-L20-T IN40L-SA-026-TA IN40-SA-060-T IN35L-SO-L48-TA IN35-SO-L22-T IN35-SO-L60-T IN40L-SA-020-TA IN40L-SA-034-TA IN35-DMTB-008-L IN35-DLTB-008-R IN35-SO-L12-T IN40-SA-018-T IN40-SA-046-T IN35L-SO-L52-TA IN35-DLTB-008-L IN35-SO-L42-T IN35L-SO-L24-TA IN35-SO-L16-T IN40L-SA-024-TA IN40-SA-050-T IN112-136 IN35L-SO-L14-TA IN35-SO-L24-T IN35L-SO-L36-TA IN35L-SO-L44-TA IN35-SO-L30-T IN40L-SA-028-TA IN35-SO-L52-T IN40L-SA-010-TA IN35L-SO-L30-TA IN35L-SO-L34-TA IN40L-SA-052-TA IN40-SA-028-T IN35L-SO-L60-TA IN35L-SO-L22-TA IN35L-SO-L26-TA IN35-SO-L38-T IN112-122 IN40-SA-036-T IN35-SO-L14-T IN40L-SA-016-TA IN40-SA-034-T IN40-SA-056-T IN35-DMTB-010-R SO-35-SO-L20-T IN35-SO-L10-T IN40L-SA-014-TA IN40-SA-030-T IN35-SO-L28-T IN40L-SA-030-TA IN40L-SA-044-TA SO-35-SO-L50-T SO-35-SO-L18-T SO-35-SO-L55-T SO-35-SO-L70-T SO-35-SO-L14-T SO-35-SO-L65-T SO-35-SO-L24-T SO-35-SO-L10-T SO-35-SO-L22-T SO-35-SO-L16-T SO-35L-SO-L20-T SO-35L-SO-L24-T SO-35-SO-L45-T SO-35-SO-L12-T SO-35L-SO-L14-T SO-35L-SO-L18-T SO-35L-SO-L45-TA SO-35L-SO-L16-T SO-35L-SO-L12-T

    Establishment Types

    Manufacture Medical Device