FDA Registration
Active
🇺🇸 United States
SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device
Reg #: 3012120772
·
FEI: 3012120772
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SEASPINE ORTHOPEDICS CORPORATION
- Registration Number
- 3012120772
- FEI Number
- 3012120772
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5770 Armada Dr
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173606
Owner / Operator
- Firm Name
- SeaSpine Orthopedics Corporation
- Operator Number
- 10049589
- Address
- 5770 Armada Dr
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-05-12 |
Proprietary Names
SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device
SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device