FDA Registration
Active
🇮🇪 Ireland
INBONE TOTAL ANKLE
Reg #: 3007740680
·
FEI: 3007740680
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- APS MATERIALS INC. IRELAND
- Registration Number
- 3007740680
- FEI Number
- 3007740680
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 26A, Waterford Industrial Estate, Cork Road, Waterford
- City
- Waterford
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K133585
Owner / Operator
- Firm Name
- APS Materials Inc. Ireland
- Operator Number
- 10029870
- Address
- Unit 26A, Waterford Industrial Estate, Cork Road, Waterford
- City
- Waterford
- State
- IE-WD
- Postal Code
- X91F670
- Country
- IE
- Correspondent
- Caroline Butler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2023-10-24 |
Proprietary Names
INBONE TOTAL ANKLE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)