FDA Registration Active 🇨🇳 China

CHANGZHOU WASTONORTHO MEDICAL APPLIANCE CO., LTD.

Reg #: 3033796901 · FEI: 3033796901 · Expires 2026
Products
5
Proprietary Names
17
Establishment Types
1
Classifications
5

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Registration Details

Registration Name
CHANGZHOU WASTONORTHO MEDICAL APPLIANCE CO., LTD.
Registration Number
3033796901
FEI Number
3033796901
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Building 16, No.9 Xihu Road, Wujin National Hi-Tech Industry Zone
City
Changzhou Jiangsu
Country
CN

Owner / Operator

Firm Name
Changzhou WastonOrtho Medical Appliance co., Ltd.
Operator Number
10091531
Address
Building 16, No.9 Xihu Road, Wujin National Hi-Tech Industry Zone
City
Changzhou
State
Jiangsu
Postal Code
213100
Country
CN
Correspondent
Jiaming WU

US Agent

Business Name
Regrek LLC
Contact Name
Leeyeo Kee
Address
19 Holly Cove Ln.
City
Dover
State
DE
ZIP
19901
Country
US
Phone
302 6089028

Products

Device Name Product Code
Bit, Drill HTW
Passer, Wire, Orthopedic HXI
Orthopedic Manual Surgical Instrument LXH
Screwdriver HXX
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

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

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)