Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021006165

FEI Number

3021006165

Entity Name

JMT CO., LTD.

City/State/Country

Yangju-si Gyeonggi, KR

Establishment Address

70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup, Yangju-si Gyeonggi 11517, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JMT Co., Ltd. (Owner Number: 10083217)

Owner / Operator Contact Address

70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup, Yangju-si, KR-41 11517, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230762

PMA Number

N/A

All Registered Proprietary Names

EDEN Peek Cage Osteo Cement Needle EDEN Spinal Fixation System EDEN ControlCath EDEN Spinal Fixation MIS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-11-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-11-03
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2021-11-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-06-24
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2025-02-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-06-19

Official Correspondent

Sang-Ok Nam

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

JMT Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021006165. Last updated year: 2026. Please use registration number 3021006165 when referencing this establishment in official correspondence.