FDA Registration
Active
🇨🇳 China
Triathlon Knee System
Reg #: 3007913880
·
FEI: 3007913880
·
Expires 2025
Products
2
Proprietary Names
2
Establishment Types
1
Classifications
2
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
- K123486
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, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2013-05-20 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-05-20 |
Proprietary Names
Triathlon Knee System
Triathlon Knee System Instrumentation
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)