BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Summa Orthopaedics Wrist System Bone Plate

    Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    247
    Establishment Types
    1
    Classifications
    3

    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
    K191972

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Plate, Fixation, Bone HRS

    Proprietary Names

    Summa Orthopaedics Wrist System Bone Plate SO-25J-DVRA-110-L ARIX Wrist System Drill guide block, 111-082-R, 111-082-L Drill guide block, 111-228-R, 111-228-L Drill guide block, 111-081-R, 111-081-L SO-25-SO-022-TA SO-111-229-R SO-25L-SO-010-TA SO-25-SO-018-TA SO-111-228-R PRO-90084 PRO-10401 Screw module, 112-129-7 PRO-90074 SO-25J-DVRA-211-R PRO-10424 SO-25L-SO-020-TA SO-111-230-L Plate module, 112-129-3 Summa Orthopaedics System Bone Screw SO-111-082-R SO-111-083-L SO-25J-DVRA-209-L SO-25L-SO-018-TA SO-25L-SO-014-TA PRO-90085 PRO-10402 SO-15L-HF-012 SO-25-SO-014-TA SO-111-227-R SO-25P-SO-028-TA SO-25R-DVRA-211-L SO-25P-SO-026-TA SO-25R-DVRA-211-R SO-25J-DVRA-211-L SO-25L-SO-024-TA SO-25P-SO-014-TA SO-112-129-3 PRO-10415 PRO-10414 SO-15L-HF-008 SO-111-082-L SO-111-095-R PRO-10555 PRO-10398 PRO-10412 PRO-10405 SO-15L-HF-010 SO-25-SO-012-TA SO-111-083-R SO-111-095-L PRO-10408 PRO-10422 Drill guide block, 111-083-R, 111-083-L PRO-90086 PRO-10403 PRO-10417 PRO-90079 PRO-10406 PRO-10420 Drill guide block, 111-095-R, 111-095-L PRO-10407 PRO-10421 Drill guide block, 111-230-R, 111-230-L Tray, 112-129 SO-25L-SO-022-TA SO-112-129 SO-25-SO-020-TA SO-111-228-L Summa Orthopaedics System Surgical Instrument SO-25J-DVRA-108-L SO-25-SO-010-TA SO-25P-SO-020-TA SO-112-129-6 Drill guide block, 111-227-R, 111-227-L Plate module, 112-129-6 Plate module, 112-129-4 SO-25J-DVRA-108-R SO-25-SO-026-TA SO-25R-DVRA-108-L SO-111-230-R SO-25P-SO-030-TA SO-25J-DVRA-110-R PRO-10416 PRO-90078 Drill guide block, 111-229-R, 111-229-L PRO-90082 SO-25-SO-024-TA SO-25R-DVRA-108-R SO-111-229-L SO-25P-SO-024-TA SO-25L-SO-008-TA SO-25-SO-016-TA SO-111-227-L PRO-10404 SO-25J-DVRA-209-R SO-25P-SO-012-TA SO-25R-DVRA-209-L SO-25L-SO-012-TA SO-25R-DVRA-110-L SO-25L-SO-016-TA PRO-90076 SO-25-SO-008-TA SO-25P-SO-018-TA SO-112-129-5 SO-25L-SO-026-TA SO-25P-SO-016-TA SO-112-129-4 PRO-10409 PRO-10423 SO-25P-SO-010-TA SO-25R-DVRA-209-R PRO-90083 PRO-10400 SO-25P-SO-022-TA SO-112-129-7 PRO-90069 Plate module, 112-129-5 PRO-90075 PRO-90088 IN25R-DVRA-211-L IN15L-HF-014 IN25-SO-012-TA PRO-10399 PRO-10413 PRO-10559 PRO-10411 INLET Distal Radius 2 System Bone Plate IN25R-DVRA-209-L IN15L-HF-013 IN25P-SO-014-TA IN25-SO-032-TA PRO-10419 PRO-90081 SO-25R-DVRA-110-R PRO-90087 PRO-90077 PRO-90068 PRO-10418 PRO-90080 IN25L-SO-038-TA IN25J-DVRA-211-R IN25-SO-028-TA IN25-SO-048-TA IN28-SO-S44-TA IN25L-SO-020-TA PRO-10557 PRO-10410 IN111-082-R IN25J-DVRA-110-R IN25P-SO-024-TA IN25R-DVRA-110-L IN15L-HF-012 IN25P-SO-010-TA IN25J-DVRA-110-L IN15L-HF-008 IN25L-SO-046-TA IN25P-SO-022-TA IN111-095-R IN25J-DVRA-108-L IN15L-HF-007 IN25P-SO-018-TA IN25-SO-050-TA IN28-SO-S46-TA IN112-129 IN25L-SO-008-TA IN25L-SO-036-TA IN111-229-R IN25R-DVRA-211-R IN25-SO-020-TA IN111-230-L IN25L-SO-026-TA IN25P-SO-028-TA INLET System Surgical Instrument IN25J-DVRA-209-R IN25L-SO-048-TA IN25-SO-044-TA IN28-SO-S40-TA IN25R-DVRA-108-L IN15L-HF-011 IN25L-SO-050-TA IN25R-DVRA-108-R IN111-083-L IN111-083-R IN25-SO-008-TA IN111-228-L IN25R-DVRA-209-R IN25L-SO-030-TA IN25R-DVRA-110-R IN25L-SO-022-TA IN25P-SO-012-TA IN25-SO-010-TA IN15L-HF-016 IN111-196-R IN25J-DVRA-209-L IN15L-HF-009 IN15L-HF-018 IN25P-SO-026-TA IN25J-DVRA-211-L IN25L-SO-018-TA IN111-082-L IN25-SO-026-TA IN25L-SO-012-TA IN25L-SO-016-TA IN25-SO-046-TA IN25-SO-042-TA IN111-227-L IN28-SO-S42-TA IN28-SO-S38-TA IN111-230-R IN25L-SO-010-TA IN25L-SO-024-TA IN25-SO-022-TA IN25-SO-034-TA IN25J-DVRA-108-R IN28-SO-S30-TA IN25P-SO-020-TA INLET System Bone Screw IN25L-SO-032-TA IN25-SO-014-TA IN15L-HF-010 IN15L-HF-020 IN25L-SO-034-TA IN25L-SO-042-TA IN111-095-L IN25P-SO-030-TA IN28-SO-S34-TA IN25-SO-016-TA IN25L-SO-044-TA IN25-SO-040-TA IN25P-SO-016-TA IN25-SO-030-TA IN28-SO-S36-TA IN111-196-L IN25L-SO-028-TA IN111-229-L IN25-SO-018-TA IN25L-SO-040-TA IN25-SO-024-TA IN25-SO-036-TA IN28-SO-S32-TA IN111-228-R IN25-SO-038-TA IN111-227-R IN15L-HF-006 IN25L-SO-014-TA

    Establishment Types

    Manufacture Medical Device