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Data / Medical devices / South Korea / Jeil Medical Corporation

Jeil Medical Corporation: FDA-registered device maker in Siheung-si Gyeonggi, South Korea, 34 510(k) clearances

Jeil Medical Corporation is registered with the FDA (registration 3014937101) in Siheung-si Gyeonggi, South Korea. It lists 13 device types. The FDA files 34 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Jeil Medical Corporation
FDA registration number
3014937101
Address
380, Beoman-ro, Siheung-si Gyeonggi, South Korea, 14928
Owner or operator
JEIL MEDICAL CORPORATION (9053245)
Roles
Manufacturer
First device listed
July 25, 2006
Registered through
2026
Brand names listed
111-069-1, Washer, 111-069-2, Washer, 111-196-L, Drill guide block, 111-196-R, Drill guide block, 112-080 KIT, 112-081 Bone Fixation Screw Kit, 112-087, Tray, 112-116, Tray and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeLXT2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
Cover, Burr HoleGXR2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Plate, BoneJEY2Manufactureraccessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-AlterableGXN2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
Screw, Fixation, IntraosseousDZL2Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 2, 2026K252246Leforte MMF SystemJEYSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
June 27, 2025K251431FIX-C PEEK ACIF SA SystemOVESubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
June 12, 2025K243973FIX-L PEEK PLIF and T-PLIF SystemMAXSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
May 30, 2025K242751ARIX Pectus Bar SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
November 8, 2024K243004Xpine Spinal Fixation SystemNKBSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
July 24, 2024K231251FlexWing Anterior Cervical Plate SystemKWQSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
December 14, 2023K231887ARIX Ankle Distal Tibia SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
July 17, 2023K231441ARIX Ankle SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
May 3, 2023K230938ARIX Humerus SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
November 22, 2022K221412ARIX Rib SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
August 24, 2022K221920ARIX Small Fragment SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
December 21, 2021K212266FIX-C PEEK Anterior Cervical Interbody SystemODPSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
October 29, 2020K202912ARIX Ankle Distal Tibia SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
September 15, 2020K201656ARIX Elbow SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
March 4, 2020K193616ARIX Ankle SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
November 12, 2019K191972ARIX Wrist SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
November 20, 2018K181806ARIX Sternal SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
October 3, 2018K180972ARIX Clavicle SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
December 1, 2017K172008ARIX Humerus SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
September 21, 2017K170705ARIX Wrist SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
August 17, 2017K170979ARIX Ankle Fibula Hook Plate SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
August 14, 2017K170780ARIX Foot System (2.3/2.8)HRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
July 27, 2017K170313ARIX Ankle Distal Tibia SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
July 24, 2017K171285ARIX Diaphysis SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
September 21, 2016K161746ARIX Hand SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
August 2, 2016K161864ARIX Foot SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
January 14, 2016K151468ARIX Wrist SystemHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
September 28, 2015K152158ARIX Ankle SystemKTTSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
June 10, 2015K143730GBR SystemJEYSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
December 22, 2014K130447SPEEDY FLAP SYSTEMGXNSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
December 18, 2013K132876ARIX HAND LOCKING SYSTEMHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
November 4, 2013K131566ARIX HAND SYSTEMHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
September 5, 2013K131311ARIX FOOT SYSTEMHRSSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
May 26, 2005K050669JEIL BONE FIXATION SYSTEMJEYSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov

Compare with other makers

Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.