Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027157194

FEI Number

3027157194

Entity Name

METICULY CO., LTD.

City/State/Country

Bangkok Krung Thep Maha Nakhon, TH

Establishment Address

Soi Chula 7, Wang Mai, Pathum Wan, 924 B bldg., Rm. B116-118, B210-212, Bangkok Krung Thep Maha Nakhon 10330, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Meticuly Co., Ltd. (Owner Number: 10087798)

Owner / Operator Contact Address

Soi Chula 7, Wang Mai, Pathum Wan, 924 B bldg., Rm. B116-118, B210-212, Bangkok, TH-NOTA 10330, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232889

PMA Number

N/A

All Registered Proprietary Names

METICULY Patient-specific titanium mesh implant METICULY Patient-specific titanium maxillofacial mesh implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2026-02-05
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2023-04-11
JEY	Plate, Bone	Dental	Class 2	872.4760	2024-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Meticuly 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
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

Similar Registrations

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3008812560	Synthes (USA) Products LLC	West Chester, PA, US
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH
3014483751	KLS MARTIN MANUFACTURING, LLC	Jacksonville, FL, US
2916714	AESCULAP, INC.	CENTER VALLEY, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027157194. Last updated year: 2026. Please use registration number 3027157194 when referencing this establishment in official correspondence.