Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009599228

FEI Number

3009599228

Entity Name

IMEDICOM CO., LTD.

City/State/Country

Gunpo-si Gyeonggi, KR

Establishment Address

#612, #709, #713, #804, #809, #815, 172, LS-ro, Gunpo-si Gyeonggi 15807, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMEDICOM Co., Ltd. (Owner Number: 10041241)

Owner / Operator Contact Address

#612, 172, LS-ro, Gunpo-si, KR-41 435824, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EZImpactor Xtrat-P EZX Blade EZX Brasseler EZX Brasseler EZX Blade EZX Tray, Brasseler EZX Tray MVX Plus SPINAUT-F MEDINAUT Flex MEDINAUT-X B-Two Inflatable bone expander system syringe B-Two Vertebral access system B-Two Inflatable bone expander system balloon catheter B-Two Vertebral Balloon Expand® Kyphoplasty System MEDINAUT-I MEDINAUT Kyphoplasty System MEDINAUT-Ix MEDINAUT-V SYNTH VRT MVX US EZImpactor MEDINAUT MAX MEDINAUT MAX Pro ZAGUAR SPINAUT-S SPINAUT-V SPINAUT-I SPINAUT-P MEDINAUT-X MEDINAUT-Ix B-Two Inflatable bone expander system syringe MEDINAUT Kyphoplasty System B-Two Vertebral access system B-Two Vertebral Balloon Expand® Kyphoplasty System MEDINAUT-I B-Two Inflatable bone expander system baloon catheter SYNTH STANDARD SYNTH BES SYNTH CDS SPINAUT-Ix(various models) MEDINAUT-Ix(various models)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-11-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-07-15
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-03-07
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-01-25
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2020-10-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-04-09
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2014-04-09
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2015-01-22
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-03-07
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-10-11
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2014-03-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-12-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-12-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-09-06
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-09-06
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-10-05

Official Correspondent

Don Soo Joo

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 2025789

Related Public Records

Same Entity

IMEDICOM 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

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3010673850	MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009599228. Last updated year: 2026. Please use registration number 3009599228 when referencing this establishment in official correspondence.