Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012697315

FEI Number

3012697315

Entity Name

CHANGZHOU XIETONG INDUSTRIES CO., LTD.

City/State/Country

CHANGZHOU Jiangsu, CN

Establishment Address

ROOM 1105, GELIN NO. 107 MISHIHE ROAD, CHANGZHOU, JIANGSU, CHINA, CHANGZHOU Jiangsu 213000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

CHANGZHOU XIETONG INDUSTRIES CO., LTD. (Owner Number: 10082488)

Owner / Operator Contact Address

ROOM 1105, GELIN NO. 107 MISHIHE ROAD, CHANGZHOU, JIANGSU, CHINA, CHANGZHOU, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CENTRAU CENTRAU YONGHUA : FORCEPS-Plate Cutter; Reduction Forceps with point; Reduction Forceps with serrated jaws; Rod Bender; Rod Holding Forceps; Rod Rotation Forceps; Vise grip pliers; Wire Cutter CENTRAU:FORCEPS-Plate Cutter; Reduction Forceps with point;Vise grip pliers; Wire Cutter; Total Wrist Joint Set; Ulna Osteotomy Instrument Set; Uterine Curette Fixator Instrument Set; Flexible Instruments Set; Gamma Interlocking Nail Instrument Set Curette; Dentistry Instruments Set; Depth Gauge; DHS/DCS Instrument Set; Distal Radius System Set; Endoscope Instruments Set; Femoral Interlocking Nails Instrument Set; Cable System Instrument Set; Calcaneal Plate Instruments Set; Cannulated Screw Instrument Set; Large Fragment Instrument Set; Maxillofacial Instruments Set; Anterior Cervical Instrument Set; Anterior Thoracic Lumbar Vertebra Instrument Set Posterior Cervical Instrument Set; Posterior Cervical Plate Instruments Set; Small/Large Fragment LCP Instrument Set; Spinal Retractor Instruments; Hip Joint Instrument Set; Humeral Interlocking Nails Instrument Set; Knee Instrument Set; Micro Surgery Instruments Set; Non-parallel compressor; Non-parallel distractor; Screw Removal Kit; Small Fragment Instrument Set; ACL Instrument Set; AF Instrument Set; Ankle Instrument Set Reduction Instrument Set; Rib Plate Instrument Set; Rongeur; Saw Bit; Sutur Forceps; Tibia Interlocking Nails Instrument Set; Spinal Surgery Instruments; Spine System Instrument Set; Distractor Instrument Set; Elastic Nails Instrument Set; Elbow Forearm Instrument Set; CENTRAU Osteotome; Pelvic Instrument Set; Pliers Orthopedic Surgical Instruments CENTRAU

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2021-10-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-10-26
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2021-10-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-10-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-10-26

Official Correspondent

DAVID ZHU

US Agent Details

JAMES ST. WU Business: HUMISS INC. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

CHANGZHOU XIETONG INDUSTRIES 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012697315. Last updated year: 2026. Please use registration number 3012697315 when referencing this establishment in official correspondence.