FDA Registration
Active
🇮🇪 Ireland
DEPUY (IRELAND)
Reg #: 9616671
·
FEI: 3002854251
·
Expires 2025
Products
10
Proprietary Names
0
Establishment Types
1
Classifications
10
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
- K231873
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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-03-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-03-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2024-03-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-03-20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-03-20 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2024-03-20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2024-03-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2024-03-20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2024-03-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-03-20 |
Establishment Types
Manufacture Medical Device