FDA Registration
Active
🇮🇹 Italy
INTRAUMA
Reg #: 3010502940
·
FEI: 3010502940
·
Expires 2026
Products
9
Proprietary Names
4
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- INTRAUMA
- Registration Number
- 3010502940
- FEI Number
- 3010502940
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Antonio Meucci 5
- City
- Bruino Torino
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K201147
Owner / Operator
- Firm Name
- INTRAUMA
- Operator Number
- 10085520
- Address
- Via Antonio Meucci, 5
- City
- Bruino
- State
- Torino
- Postal Code
- 10090
- Country
- IT
- Correspondent
- Stefano Pullega
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-11-24 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2022-07-19 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-09-27 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2023-09-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-09-27 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-11-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-11-24 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-11-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
Proprietary Names
INTRAUMA SURGICAL INSTRUMENT
Elos Intramedullary Nailing System
Kite Distal Fibula Kit
Wristar MultiAx Distal Radius Kit
Establishment Types
Manufacture Medical Device