FDA Registration
Active
🇺🇸 United States
SPINAL ELEMENTS, INC.
Reg #: 3004893332
·
FEI: 3004893332
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SPINAL ELEMENTS, INC.
- Registration Number
- 3004893332
- FEI Number
- 3004893332
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3115 Melrose Dr Suite 200
- City
- CARLSBAD
- State
- CA
- ZIP
- 92010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222833
Owner / Operator
- Firm Name
- Spinal Elements
- Operator Number
- 9048980
- Address
- 3115 Melrose Dr Suite 200
- City
- Carlsbad
- State
- CA
- Postal Code
- 92010
- Country
- US
- Correspondent
- Cheryl Allen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-06-01 |
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198