FDA Registration
Active
🇺🇸 United States
TETROUS, INC.
Reg #: 3029780995
·
FEI: 3029780995
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- TETROUS, INC.
- Registration Number
- 3029780995
- FEI Number
- 3029780995
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2021 Midwest Rd Ste 101
- City
- Oak Brook
- State
- IL
- ZIP
- 60523
- Country
- US
Owner / Operator
- Firm Name
- Tetrous, Inc.
- Operator Number
- 10090043
- Address
- 2021 Midwest Road, Suite 101
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Andy Carter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-05-15 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-02-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-02-06 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2024-02-06 |
Proprietary Names
EnFix Instrument Tray
EnFix Guide Wire
Tetrous Guide Wire
EnFix Introducer Probe
EnFix Awl
Establishment Types
Manufacture Medical Device