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
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2024-10-12 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2024-10-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-10-12 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2024-10-12 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-10-12 |
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)