Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031235905

FEI Number

3031235905

Entity Name

SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Suite B605, Building No.1, YESUN INTELLIGENT COMMUNITY II, 1301-76 Guanguang Rd., Longhua District, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Dazhou Medical Technology Co., Ltd. (Owner Number: 10090591)

Owner / Operator Contact Address

Suite B605, Building No.1, YESUN INTELLIGENT COMMUNITY II, 1301-76 Guanguang Rd., Longhua District, Shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthopedic manual surgical instrument Retaining Screw Fixture Mount/Transfer Step Drill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-04-16
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-04-19
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2026-04-19

Official Correspondent

Shanshan Ju

US Agent Details

JINGZHOU YANG Email: yangjingzhou@dazhoumedical.com Phone: (857) 6363862

Related Public Records

Same Entity

Shenzhen Dazhou Medical Technology Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3018033084	NEXT GENERATION TOOLING INC	Akron, OH, US
3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031235905. Last updated year: 2026. Please use registration number 3031235905 when referencing this establishment in official correspondence.