Data / Medical devices / South Korea / Jeil Medical Corporation

Jeil Medical Corporation: FDA-registered device maker in Seoul, South Korea, 54 510(k) clearances

Name: Jeil Medical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jeil Medical Corporation is registered with the FDA (registration 3004049923) in Seoul, South Korea. It lists 60 device types. The FDA files 54 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Jeil Medical Corporation

FDA registration number: 3004049923
Address: 702,703,704,705,706,707,804,805,807,812,815-ho 55, Digital-ro 34-gil, Guro-gu, Seoul, South Korea, 08378
Owner or operator: JEIL MEDICAL CORPORATION (9053245)
Roles: Manufacturer
First device listed: April 2, 2004
Registered through: 2026
Brand names listed: 01-03-3035, 05-03-2528, 05-07-2528, 05-08-2528, 110-048, 111-001, 111-003, 111-004 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	KTW	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Battery, Replacement, Rechargeable	MOQ	1	Manufacturer	accessdata.fda.gov
Bender	HXW	1	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Countersink	HWW	1	Manufacturer	accessdata.fda.gov
Cover, Burr Hole	GXR	2	Manufacturer	accessdata.fda.gov
Cutter, Surgical	FZT	1	Manufacturer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Manufacturer	accessdata.fda.gov
Depressor, Orbital	HNX	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Manufacturer	accessdata.fda.gov
Fastener, Plate, Cranioplasty	HBW	2	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Forceps, Rongeur, Surgical	EMH	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Gouge, Surgical, General & Plastic Surgery	GDH	1	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Instrument, Cutting, Operative	EKD	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	1	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	Manufacturer	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Alterable	GWO	2	Manufacturer	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-Alterable	GXN	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Pliers, Operative	EJY	1	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Screwdriver, Skullplate	GXL	1	Manufacturer	accessdata.fda.gov
Stylet, Surgical, General & Plastic Surgery	GAH	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Trocar, Ent	KTE	1	Manufacturer	accessdata.fda.gov
Washer, Bolt, Nut, Non-Spinal, Metallic	NDG	2	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 2, 2026	K252246	Leforte MMF System	JEY	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 10, 2025	K252826	ARIX Femur Nail System	HSB	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
June 27, 2025	K251431	FIX-C PEEK ACIF SA System	OVE	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
June 12, 2025	K243973	FIX-L PEEK PLIF and T-PLIF System	MAX	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
May 30, 2025	K242751	ARIX Pectus Bar System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
April 22, 2025	K242247	ARIX Femur Nail System	HSB	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
February 18, 2025	K243915	FIX-C 3D Ti ACIF System	ODP	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
November 8, 2024	K243004	Xpine Spinal Fixation System	NKB	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
July 24, 2024	K231251	FlexWing Anterior Cervical Plate System	KWQ	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
March 11, 2024	K233912	ARIX Cannulated Screw System	HWC	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 14, 2023	K231887	ARIX Ankle Distal Tibia System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
July 17, 2023	K231441	ARIX Ankle System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
May 3, 2023	K230938	ARIX Humerus System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
November 22, 2022	K221412	ARIX Rib System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
August 24, 2022	K221920	ARIX Small Fragment System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 21, 2021	K212266	FIX-C PEEK Anterior Cervical Interbody System	ODP	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
October 29, 2020	K202912	ARIX Ankle Distal Tibia System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
September 15, 2020	K201656	ARIX Elbow System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
March 4, 2020	K193616	ARIX Ankle System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
November 26, 2019	K192417	ARIX Cannulated Screw System	HWC	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
November 12, 2019	K191972	ARIX Wrist System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
November 20, 2018	K181806	ARIX Sternal System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
October 3, 2018	K180972	ARIX Clavicle System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 1, 2017	K172008	ARIX Humerus System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
September 21, 2017	K170705	ARIX Wrist System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
September 11, 2017	K170368	Sterile NS System	GWO	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
August 17, 2017	K170979	ARIX Ankle Fibula Hook Plate System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
August 14, 2017	K170780	ARIX Foot System (2.3/2.8)	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
July 27, 2017	K170313	ARIX Ankle Distal Tibia System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
July 24, 2017	K171285	ARIX Diaphysis System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
February 23, 2017	K161335	Dual Top Screw System	OAT	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 27, 2016	K163308	SMARTO	KIJ	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
September 21, 2016	K161746	ARIX Hand System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
August 2, 2016	K161864	ARIX Foot System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
January 14, 2016	K151468	ARIX Wrist System	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
September 28, 2015	K152158	ARIX Ankle System	KTT	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
September 17, 2015	K150965	LeForte System II	JEY	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
June 10, 2015	K143730	GBR System	JEY	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 22, 2014	K130447	SPEEDY FLAP SYSTEM	GXN	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
July 2, 2014	K141452	LEFORTE NEURO SYSTEM BONE PLATE AND SCREW	GWO	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 18, 2013	K132876	ARIX HAND LOCKING SYSTEM	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
November 4, 2013	K131566	ARIX HAND SYSTEM	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
September 5, 2013	K131311	ARIX FOOT SYSTEM	HRS	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
May 18, 2012	K112457	LEFORTE SYSTEM BONE PLATE & SCREW	JEY	Substantially Equivalent	Arkin Consulting Group	accessdata.fda.gov
February 22, 2012	K112812	LEFORTE NEURO SYSTEM BONE PLATE	GWO	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
February 8, 2011	K101902	J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030	DZL	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
January 26, 2011	K103778	LEFORTE NEURO SYSTEM BONE PLATE	JEY	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
December 17, 2010	K101563	SMARTO	KIJ	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
November 13, 2009	K091686	LEFORTE NEUROSYSTEM BONE SCREW	HWC	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
October 2, 2009	K091679	LEFORTE SYSTEM BONE PLATE	JEY	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
May 26, 2005	K050669	JEIL BONE FIXATION SYSTEM	JEY	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
February 24, 2004	K033767	DUAL TOP ANCHOR SYSTEM SCREWS	DZE	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
April 18, 2003	K023365	LEFORTE SYSTEM BONE SCREW	HWC	Substantially Equivalent	Jeil Medical Corporation	accessdata.fda.gov
October 25, 2002	K023360	LEFORTE SYSTEM BONE PLATE	KTW	Substantially Equivalent	Jeil Medical Corporation	accessdata.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.