Is this your brand? Sign in to claim ownership.
Sign in to claim this brandINTRAUMA SPA
US
Last updated May 23, 2026
What INTRAUMA SPA makes
Intrauuma SPA manufactures orthopaedic fixation devices, including non-sliding bone screws, femur intramedullary nails, and non-bioabsorbable screws and plates for surgical stabilization. Their portfolio also includes reusable surgical tools such as drill guides, fluted drill bits, and medical rulers, as well as orthopaedic implant aiming arms for precision alignment during procedures.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device compliance standards for orthopaedic hardware.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Intrauuma SPA manufacture?
Intrauuma SPA specializes in orthopaedic fixation devices, including non-sliding bone screws, femur intramedullary nails, and non-bioabsorbable screws and plates. Their product range also covers reusable surgical tools like drill guides, fluted drill bits, medical rulers, and orthopaedic implant aiming arms. These devices are designed for surgical stabilization and precision alignment in orthopaedic procedures.
Where is Intrauuma SPA based?
Intrauuma SPA operates from the United States. The company develops and manufactures its devices in compliance with applicable medical device regulations and standards for orthopaedic hardware in that region.
Which regulatory registries list Intrauuma SPA’s devices?
Intrauuma SPA’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class II orthopaedic hardware, ensuring traceability and compliance with U.S. regulatory requirements.
How are Intrauuma SPA’s devices classified by regulatory authorities?
All of Intrauuma SPA’s listed devices fall under FDA Class II regulation. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as orthopaedic fixation hardware.
What distinguishes Intrauuma SPA’s reusable surgical tools from their implantable devices?
Intrauuma SPA’s reusable surgical tools—such as drill guides, fluted drill bits, and medical rulers—are designed for repeated use in operating rooms, ensuring precision and efficiency during procedures. In contrast, their implantable devices, like non-sliding bone screws and intramedullary nails, are intended for permanent or long-term placement within the body to stabilize fractures or support bone healing. Both categories adhere to Class II regulatory standards but serve distinct roles in surgical workflows.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 387588051
Catalogue (151)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elos | 200.4105 | FDA UDI | Class II | Active |
| Elos Instruments | SE203 | FDA UDI | Class II | Active |
| Elos | 200.4005 | FDA UDI | Class II | Active |
| Cortical Screw | 120.2736 | FDA UDI | Class II | Active |
| Elos | 200.4095 | FDA UDI | Class II | Active |
| Elos | 200.3606 | FDA UDI | Class II | Active |
| Elos Instruments | SE218 | FDA UDI | Class II | Active |
| Elos Instruments | SE235 | FDA UDI | Class II | Active |
| Syndesmosis Screw | 120.2932 | FDA UDI | Class II | Active |
| Elos | 200.4205 | FDA UDI | Class II | Active |
| Elos | 200.4406 | FDA UDI | Class II | Active |
| Locking Screw | 120.2522 | FDA UDI | Class II | Active |
| Elos Instruments | SE202 | FDA UDI | Class II | Active |
| Cortical Screw | 120.2730 | FDA UDI | Class II | Active |
| Elos | 200.3601 | FDA UDI | Class II | Active |
| Syndesmosis Screw | 120.2938 | FDA UDI | Class II | Active |
| Kite | KM2.7111 | FDA UDI | Class II | Active |
| Elos | 200.4206 | FDA UDI | Class II | Active |
| Locking Screw | 120.2538 | FDA UDI | Class II | Active |
| Elos Instruments | SE206A | FDA UDI | Class II | Active |
| Elos | 200.4075 | FDA UDI | Class II | Active |
| Syndesmosis Screw | 120.2958 | FDA UDI | Class II | Active |
| Elos | 200.3206 | FDA UDI | Class II | Active |
| Elos | 200.1105 | FDA UDI | Class II | Active |
| Syndesmosis Screw | 120.2942 | FDA UDI | Class II | Active |
| Syndesmosis Screw | 120.2956 | FDA UDI | Class II | Active |
| Cortical Screw | 120.2740 | FDA UDI | Class II | Active |
| Elos Instruments | SE220 | FDA UDI | Class II | Active |
| Elos | 200.4085 | FDA UDI | Class II | Active |
| Cortical Screw | 120.2718 | FDA UDI | Class II | Active |
| Cortical Screw | 120.2738 | FDA UDI | Class II | Active |
| Elos | 200.1100 | FDA UDI | Class II | Active |
| Elos Instruments | SE2.S001 | FDA UDI | Class II | Active |
| Elos | 200.3802 | FDA UDI | Class II | Active |
| Elos | 200.1090 | FDA UDI | Class II | Active |
| Elos | 200.3405 | FDA UDI | Class II | Active |
| Elos Instruments | SE221 | FDA UDI | Class II | Active |
| Locking Screw | 120.2520 | FDA UDI | Class II | Active |
| Elos | 200.4090 | FDA UDI | Class II | Active |
| Elos | 200.4055 | FDA UDI | Class II | Active |
| Locking Screw | 120.2546 | FDA UDI | Class II | Active |
| Trial Plate | T120.71XX | FDA UDI | Class II | Active |
| Kite | KM2.7112 | FDA UDI | Class II | Active |
| Elos | 200.3402 | FDA UDI | Class II | Active |
| Cortical Screw | 120.2716 | FDA UDI | Class II | Active |
| Locking Screw | 120.2528 | FDA UDI | Class II | Active |
| Elos | 200.0001 | FDA UDI | Class II | Active |
| Elos Instruments | SE204 | FDA UDI | Class II | Active |
| Syndesmosis Screw | 120.2960 | FDA UDI | Class II | Active |
| Elos | 200.4401 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Intrauma Bruino Torino · IT FEI 3010502940