FDA Registration
Active
🇮🇪 Ireland
Apex Nailing System Instrumentation
Reg #: 3014976005
·
FEI: 3014976005
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ORTHOXEL
- Registration Number
- 3014976005
- FEI Number
- 3014976005
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Cube House, Cork Business and Technology Park, Model Farm Road, Bishopstown
- City
- Cork
- Country
- IE
Owner / Operator
- Firm Name
- OrthoXel
- Operator Number
- 10058878
- Address
- Cube House,, Cork Business and Technology Park, Model Farm Road
- City
- Cork
- State
- IE-NOTA
- Postal Code
- T12 H966
- Country
- IE
- Correspondent
- Mark Moynihan
US Agent
- Business Name
- MCRA, LLC
- Contact Name
- Hollace Rhodes
- Address
- 1050 K Street NW, Suite 1000
- City
- Washington
- State
- DC
- ZIP
- 20001
- Country
- US
- [email protected]
- Phone
- 202 5525807
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-11-04 |
Proprietary Names
Apex Nailing System Instrumentation
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198