FDA Registration
Active
🇨🇳 China
Trident II Tritanium Acetabular Cup System and 6.5mm Low Profile Hex Screws (Solidback, Clusterhole and Multihole)
Reg #: 3007913880
·
FEI: 3007913880
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Stryker (Suzhou) Medical Technology Co.,Ltd.
- Registration Number
- 3007913880
- FEI Number
- 3007913880
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.18 WuXiang, EPZ Zone A, 200 Suhong Rd
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K161569
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
US Agent
- Business Name
- STRYKER CORP
- Contact Name
- Jody Powell
- Address
- 4100 East Milham Ave
- City
- Kalamazoo
- State
- MI
- ZIP
- 49001
- Country
- US
- [email protected]
- Phone
- 269 3237700 ext. 3718
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2016-10-17 |
Proprietary Names
Trident II Tritanium Acetabular Cup System and 6.5mm Low Profile Hex Screws (Solidback, Clusterhole and Multihole)
Stryker Orthopaedics Instruments
Establishment Types
Manufacture Medical Device