Changzhou Wastonortho Medical Appliance Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 5 device types.
Changzhou Wastonortho Medical Appliance Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bit, Drill, Screwdriver and 3 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | CHANGZHOU WASTONORTHO MEDICAL APPLIANCE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033796901 |
| FEI number | 3033796901 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 16, No.9 Xihu Road, Wujin National Hi-Tech Industry Zone |
| Postal code | 213100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bit, Drill | Class 1 | 8mm I/M Step Drill SFP | 2024 | 27 |
| Orthopedic Manual Surgical Instrument | Class 1 | Quick Release Distal Cut Guide Wide SFP; TriMax Posterior 4 in 1 Cut Guide Close Size;, Flexible Headed & Straight Pin Puller SFP; Tib Tray Impactor SFP; Headed Pin SFP; Headed Pin Driver SFP;, Patella Calipers SFP; Patella Sizing Temp; Clamp.SFP; Patella Trial; Patella Sizing Temp.29-32 SFP;, TriMax Femoral Trial Extractor SFP; TriMax Universal Femoral Trial; TriMax Balancing Guide SFP; Tibial Tray Trial;, Tib Insert Clamp SFP; Patella Cementing Clamp Head 35mm SFP; Ratcheting Patella Cementing Clamp w/Radel Head SFP;, Notched I/M Alignment Guide SFP; Alignment Rod SFP; Alignment Rods with Coupling-Long SFP; Femoral Impactor SFP; and 7 more | 2024 | 53 |
| Passer, Wire, Orthopedic | Class 1 | Troch Nail Reducer, SFP | 2024 | 9 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | Ortho Development Balanced Knee System | 2024 | 21 |
| Screwdriver | Class 1 | Troch Nail Ball Locking Hex Driver, Nail, SFP | 2024 | 18 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | Hip system implants, Acetabular shells, Hip stems, Orthopedic implants, Surgical instruments |
| Certifications | ISO, CE |
| Export markets | International (Japan, USA) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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