FDA Registration
Active
🇮🇪 Ireland
Accolade Hip System
Reg #: 9616680
·
FEI: 3002459190
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
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
- K052542
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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2008-06-17 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2008-06-17 |
Proprietary Names
Accolade Hip System
Establishment Types
Manufacture Medical Device