FDA Registration
Active
🇺🇸 United States
SetX Pedicle Screw System
Reg #: 2028632
·
FEI: 1000125025
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- EAGLE MEDICAL PACKAGING STERILIZATION, INC.
- Registration Number
- 2028632
- FEI Number
- 1000125025
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2921 UNION RD
- City
- PASO ROBLES
- State
- CA
- ZIP
- 93446
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160986
Owner / Operator
- Firm Name
- EAGLE MEDICAL, INC.
- Operator Number
- 9005849
- Address
- 2921 UNION RD, SUITE A, --
- City
- PASO ROBLES
- State
- CA
- Postal Code
- 93446
- Country
- US
- Correspondent
- JODY - BIRKS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-12-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-12-03 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-12-03 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-12-03 |
Proprietary Names
SetX Pedicle Screw System
Establishment Types
Repack or Relabel Medical Device