Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030531649

FEI Number

3030531649

Entity Name

Changzhou Master Precision Tool Co.,Ltd

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Building 8,Chaofan Industrial Park, No. 135, Hongxi Road, Niutang Town, Wujin district, Changzhou City, Changzhou Jiangsu 213163, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Changzhou Master Precision Tool Co.,Ltd (Owner Number: 10089776)

Owner / Operator Contact Address

Building 8,Chaofan Industrial Park, No. 135, Hongxi Road, Niutang Town, Wujin district, Changzhou City, Changzhou, CN-JS 213163, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BROACH/BROACH A/BROACH B/BROACH C/BROACH D/BROACH E/BROACH F/BROACH G/BROACH H/BROACH I/BROACH J/BROACH HANDLE STEM HOLDER ASSEMBLY/STEM IMPACTOR/STEM EXTRACTOR/GUIDE/TRIAL CUP/Optional Calcar Planer /Preoperative broach/ Box Chisel/Femoral stem installer/Screw Forceps/Acecabular Cup Installer TIBIAL HOLDER/4 IN 1 RESECTION GUIDE/TIBIA EM ANKLE CLAMP ASSEMBLY/PATELLA OSTEOMY GUIDE/FEMORAL SIZER/ DISTAL FEMORAL ALIGNMENT GUIDE/HOUSING REAMER DOME/PATELLA REAMER/HUMERUS REAMER REAMER/BONEALL ACETABULAR REAMER-BONEALL/BONEST ACETABULAR REAMER-BONEST/ BONESKT ACETABULAR REAMER-BONESKT/ /REAMER HAND/OFFSET REAMER HANDLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTQ	Broach	Orthopedic	Class 1	888.4540	2024-01-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-01-08
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-01-08

Official Correspondent

Kejia Wang

US Agent Details

Zheng Xu Email: Cathygeng2007@Gmail.Com Phone: (248) 5508758

Related Public Records

Same Entity

Changzhou Master Precision Tool 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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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 3030531649. Last updated year: 2026. Please use registration number 3030531649 when referencing this establishment in official correspondence.