FDA Registration
Active
🇮🇪 Ireland
ORTHOXEL
Reg #: 3014976005
·
FEI: 3014976005
·
Expires 2026
Products
11
Proprietary Names
6
Establishment Types
3
Classifications
11
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Registration Details
- Registration Name
- ORTHOXEL
- Registration Number
- 3014976005
- FEI Number
- 3014976005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Cube House, Cork Business and Technology Park, Model Farm Road, Bishopstown
- City
- Cork
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K170972
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
- Hannah Irwin
- Address
- 803 7th St Nw Fl 3
- City
- Washington
- State
- DC
- ZIP
- 20001
- Country
- US
- [email protected]
- Phone
- 202 5525820
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-11-04 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-11-21 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-11-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-09-26 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2019-09-26 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-09-26 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2022-08-18 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-09-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-09-26 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-09-26 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-09-26 |
Proprietary Names
Apex Nailing System Instrumentation
Apex Tibial Nailing System
Vertex Hip Fracture Nailing System
Apex Tibial Nailing System Instrumention
Apex Tibial Nailing System Instrumentation
Apex Femoral Nailing System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198