FDA Registration
Active
🇺🇸 United States
Neo Pedicle Screw System
Reg #: 3014003062
·
FEI: 3014003062
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-11-05 |
Proprietary Names
Neo Pedicle Screw System
Ratchet Handle - 1/4", NS
Screwdriver Adaptor - AO, NS
Screwdriver Handle, NS
Screwdriver kit
Set screwdriver
Screwdriver Converter - Hudson, NS
Ratchet Screwdriver, NS
Screwdriver Converter - AO, NS
Screwdriver Adaptor - 1/4", NS
Screwdriver Adaptor - Hudson, NS
Ratchet Handle - Hudson, NS
Set-screwdriver (10x1)
Establishment Types
Complaint File Establishment per 21 CFR 820.198