FDA Registration
Active
🇮🇪 Ireland
Trident II Tritanium Acetabular Cup System and 6.5mm Low Profile Hex Screws (Solidback, Clusterhole and Multihole)
Reg #: 3013014058
·
FEI: 3013014058
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Stryker Anngrove
- Registration Number
- 3013014058
- FEI Number
- 3013014058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Anngrove Building, IDA Business & Technology Park, Carrigtwohill
- City
- Cork Munster
- Country
- IE
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
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 for Another Party (Contract Manufacturer)