FDA Registration
Active
🇮🇪 Ireland
Pinnacle, Gription (hip)
Reg #: 9616671
·
FEI: 3002854251
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- DEPUY (IRELAND)
- Registration Number
- 9616671
- FEI Number
- 3002854251
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOUGHBEG, RINGASKIDDY
- City
- CO. CORK Munster
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K100391
Owner / Operator
- Firm Name
- DePuy Synthes, Inc.
- Operator Number
- 1818910
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
US Agent
- Business Name
- DePuy Synthes
- Contact Name
- Patrick McCullagh
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
- [email protected]
- Phone
- 267 3005417
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2011-01-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2011-01-28 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2011-01-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2011-01-28 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2011-01-28 |
Proprietary Names
Pinnacle, Gription (hip)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility