Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033519208

FEI Number

3033519208

Entity Name

MEDIFIELD MEDICAL CO., LTD.

City/State/Country

Pocheon Gyeonggi, KR

Establishment Address

94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, 1st floor, Gadong, Pocheon Gyeonggi 11154, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDIFIELD MEDICAL CO., LTD. (Owner Number: 10091668)

Owner / Operator Contact Address

94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, 1st floor, Gadong, Pocheon, KR-41 11154, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tray; The Montblanc Radius Plate System Tray; The Montblanc Ankle Plate System Montblanc Plate System Depth Gauge; Green Drill Bit; 2mm Screw Holder; 3.6mm Cortical Drill Guide; Radius Drill Bit; 2.7mm Screw Holder; 3mm Guide Block Standard(Left) Guide Block Wide(Left) Depth Gauge; Blue Locking Drill Guide; Radius Guide Block Narrow(Left) Guide Block Narrow(Right) AO Type Handle Driver Shaft; 3mm Lag Drill Bit; 3.6mm Guide Block Standard(Right) Lag Drill Guide; Ankle Plate Track; 1.3mm Locking Drill Guide; Ankle Cortical Drill Guide; Ankle Guide Block Wide(Right) Guide Block Drill Guide; Radius Driver Shaft; 3.5mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-10-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-10-28

Official Correspondent

yourim Park

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

MEDIFIELD MEDICAL 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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

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-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033519208. Last updated year: 2026. Please use registration number 3033519208 when referencing this establishment in official correspondence.