FDA Registration
Active
🇮🇪 Ireland
Triathlon Total Knee System
Reg #: 9616680
·
FEI: 3002459190
·
Expires 2025
Products
6
Proprietary Names
3
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- STRYKER IRELAND OSTEONICS
- Registration Number
- 9616680
- FEI Number
- 3002459190
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Tullagreen Building, IDA Business & Technology Park, Carrigtwohill
- City
- Cork Munster
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K172326
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-11-03 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2017-11-03 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2017-11-03 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2017-11-03 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2017-11-03 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2017-11-03 |
Proprietary Names
Triathlon Total Knee System
Triathlon PKR
Restoris MCK
Establishment Types
Manufacture Medical Device