Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033796901

FEI Number

3033796901

Entity Name

CHANGZHOU WASTONORTHO MEDICAL APPLIANCE CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Building 16, No.9 Xihu Road, Wujin National Hi-Tech Industry Zone, Changzhou Jiangsu 213100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Changzhou WastonOrtho Medical Appliance co., Ltd. (Owner Number: 10091531)

Owner / Operator Contact Address

Building 16, No.9 Xihu Road, Wujin National Hi-Tech Industry 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

8mm I/M Step Drill SFP Troch Nail Reducer, SFP TriMax Tibial Alignment Rod Adapter SFP; TriMax Extramedullary Guide Tower SFP; Patella Sizing Template Size 35-38-41 SFP; Quick Release Distal Cut Guide Scafolding SFP; Tib Insert Clamp SFP; Patella Cementing Clamp Head 35mm SFP; Ratcheting Patella Cementing Clamp w/Radel Head SFP; TriMax Femoral Trial Extractor SFP; TriMax Universal Femoral Trial; TriMax Balancing Guide SFP; Tibial Tray Trial; Flexible Headed & Straight Pin Puller SFP; Tib Tray Impactor SFP; Headed Pin SFP; Headed Pin Driver SFP; Femoral Impactor SFP; Flexible Headed & Straight Pin Puller SFP; Tib Tray Impactor SFP; T-Handle Long SFP; Notched I/M Alignment Guide SFP; Alignment Rod SFP; Alignment Rods with Coupling-Long SFP; Femoral Impactor SFP; Tibial Tray Alignment Handle SFP; TriMax Tibial Punch Tower SFP; TriMax Tibial Punch Cemented; Patella Calipers SFP; Patella Sizing Temp; Clamp.SFP; Patella Trial; Patella Sizing Temp.29-32 SFP; TriMax Extramedullary Guide Ankle Clamp SFP; TriMax 2/10mm Tib Stylus SFP; T-Handle Long SFP; Notched I/M Alignment Guide SFP; Alignment Rod SFP; Alignment Rods with Coupling-Long SFP; Quick Release Distal Cut Guide Wide SFP; TriMax Posterior 4 in 1 Cut Guide Close Size; TriMax Extramedullary Tibial Cut Guide; TriMax Cut Feeler Gage SFP Troch Nail Ball Locking Hex Driver, Nail, SFP ORTHO DEVELOPMENT BALANCED KNEE SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2024-10-12
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2024-10-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-10-12
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2024-10-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-10-12

Official Correspondent

Jiaming WU

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Changzhou WastonOrtho Medical Appliance 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
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

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.

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3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
3023265483	PHEN'X TECHNOLOGIES	Chassieu Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033796901. Last updated year: 2026. Please use registration number 3033796901 when referencing this establishment in official correspondence.