Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012863589

FEI Number

3012863589

Entity Name

CHANGZHOU YONGHUA MEDICAL INSTRUMENTS CO.,LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.28 Changfan Road, Wujin Economic Development Zone, Changzhou Jiangsu 213100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou Yonghua Medical Instruments Co.,Ltd (Owner Number: 10053295)

Owner / Operator Contact Address

No.28 Changfan Road, Wujin Economic Development Zone, Changzhou, CN-JS 213100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Yonghua Yonghua Yonghua Yonghua Yonghua Yonghua

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTQ	Broach	Orthopedic	Class 1	888.4540	2021-11-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-07-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-07-30
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-11-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-01-10
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-01-10
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-07-30

Official Correspondent

No official correspondent registered.

US Agent Details

Xuehong Roeper Email: Susanshi365@outlook.com Phone: (213) 5100656

Related Public Records

Same Entity

Changzhou Yonghua Medical Instruments 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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

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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3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH
3009973844	TriPoint Surgical	Columbia City, IN, US
3010388970	GUANGZHOU AQUILA PRECISE TOOLS LIMITED	Guangzhou City Guangdong, CN
3003596442	TRIGON AMERICA LLC	Aurora, IL, US
1038671	EXACTECH, INC.	GAINESVILLE, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012863589. Last updated year: 2026. Please use registration number 3012863589 when referencing this establishment in official correspondence.