FDA Registration
Active
🇺🇸 United States
BonOs Inject
Reg #: 3014003062
·
FEI: 3014003062
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- NEO SPINE USA INC.
- Registration Number
- 3014003062
- FEI Number
- 3014003062
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 411 Hackensack Avenue #200-126
- City
- Hackensack
- State
- NJ
- ZIP
- 07601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202458
Owner / Operator
- Firm Name
- Neo Spine USA Inc.
- Operator Number
- 10056088
- Address
- 411 Hackensack Avenue #200-126
- City
- Hackensack
- State
- NJ
- Postal Code
- 07601
- Country
- US
- Correspondent
- Jonas Larsson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2021-06-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-06-15 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2021-06-15 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2021-06-15 |
Proprietary Names
BonOs Inject
NEO Pedicle Screw System
Establishment Types
Complaint File Establishment per 21 CFR 820.198