FDA Registration
Active
🇺🇸 United States
ZESPINE SI Joint Fusion System
Reg #: 3009790163
·
FEI: 3009790163
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- AEGIS SPINE
- Registration Number
- 3009790163
- FEI Number
- 3009790163
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 130 McCormick Ave, Suite 106
- City
- Costa Mesa
- State
- CA
- ZIP
- 92626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210035
Owner / Operator
- Firm Name
- Aegis Spine
- Operator Number
- 10031416
- Address
- 130 McCormick Ave, Suite 106
- City
- Costa Mesa
- State
- CA
- Postal Code
- 92626
- Country
- US
- Correspondent
- Tony Ahn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2021-02-23 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-02-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-02-23 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2021-02-23 |
Proprietary Names
ZESPINE SI Joint Fusion System
Paeon Posterior Cervical Fixation System
Elatus Lumbar Plate System
Paeon Anterior Cervical Plate System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility