FDA Registration Active 🇨🇳 China

TriMax Femoral Trial Extractor SFP; TriMax Universal Femoral Trial; TriMax Balancing Guide SFP; Tibial Tray Trial;

Reg #: 3033796901 · FEI: 3033796901 · Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1

Registration Details

Registration Name
CHANGZHOU WASTONORTHO MEDICAL APPLIANCE CO., LTD.
Registration Number
3033796901
FEI Number
3033796901
Status
Active
Expiry Year
2025
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
Orthopedic Manual Surgical Instrument LXH

Proprietary Names

TriMax Femoral Trial Extractor SFP; TriMax Universal Femoral Trial; TriMax Balancing Guide SFP; Tibial Tray Trial; Notched I/M Alignment Guide SFP; Alignment Rod SFP; Alignment Rods with Coupling-Long SFP; Femoral Impactor SFP; Quick Release Distal Cut Guide Wide SFP; TriMax Posterior 4 in 1 Cut Guide Close Size; Tib Insert Clamp SFP; Patella Cementing Clamp Head 35mm SFP; Ratcheting Patella Cementing Clamp w/Radel Head SFP; Patella Calipers SFP; Patella Sizing Temp; Clamp.SFP; Patella Trial; Patella Sizing Temp.29-32 SFP; Tibial Tray Alignment Handle SFP; TriMax Tibial Punch Tower SFP; TriMax Tibial Punch Cemented; Femoral Impactor SFP; Flexible Headed & Straight Pin Puller SFP; Tib Tray Impactor SFP; T-Handle Long SFP; TriMax Extramedullary Tibial Cut Guide; TriMax Cut Feeler Gage SFP TriMax Extramedullary Guide Ankle Clamp SFP; TriMax 2/10mm Tib Stylus SFP; Flexible Headed & Straight Pin Puller SFP; Tib Tray Impactor SFP; Headed Pin SFP; Headed Pin Driver 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; T-Handle Long SFP; Notched I/M Alignment Guide SFP; Alignment Rod SFP; Alignment Rods with Coupling-Long SFP;

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)