FDA Registration
Active
🇮🇪 Ireland
DePuy Corail AMT Hip Prosthesis
Reg #: 3015516266
·
FEI: 3015516266
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Depuy Ireland UC
- Registration Number
- 3015516266
- FEI Number
- 3015516266
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Loughbeg, Ringaskiddy
- City
- Co. Cork Munster
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K192946
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, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2020-09-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2020-09-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-09-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2020-09-15 |
Proprietary Names
DePuy Corail AMT Hip Prosthesis
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device