FDA Registration
Active
🇺🇸 United States
Unassigned
Reg #: 3010863450
·
FEI: 3010863450
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- AXIAL MEDICAL
- Registration Number
- 3010863450
- FEI Number
- 3010863450
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 65 Richard Rd
- City
- Ivyland
- State
- PA
- ZIP
- 18974
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061202
Owner / Operator
- Firm Name
- Axial Medical
- Operator Number
- 10046914
- Address
- 65 Richard Road
- City
- Ivyland
- State
- PA
- Postal Code
- 18974
- Country
- US
- Correspondent
- Wolf Stefany
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-03-17 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-03-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-03-17 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-03-17 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-03-17 |
Proprietary Names
Unassigned
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)