FDA Registration
Active
🇮🇪 Ireland
Exeter IM Plug
Reg #: 9616680
·
FEI: 3002459190
·
Expires 2025
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
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
- K173499
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, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2018-03-23 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-03-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-03-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-03-23 |
Proprietary Names
Exeter IM Plug
Exeter Related Instrumentation
UHR Bipolar Femoral Heads
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Unitrax Modular Endo Heads
Establishment Types
Manufacture Medical Device