Data / Medical devices / Italy / Intrauma
Intrauma: FDA-registered device maker in Bruino Torino, Italy, 3 510(k) clearances
Intrauma is registered with the FDA (registration 3010502940) in Bruino Torino, Italy. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 12, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010502940
- Address
- Via Antonio Meucci 5, Bruino Torino, Italy, 10090
- Owner or operator
- INTRAUMA (10085520)
- Roles
- Manufacturer
- First device listed
- July 19, 2022
- Registered through
- 2027
- Brand names listed
- Elos Intramedullary Nailing System, INTRAUMA SURGICAL INSTRUMENT, Kite Distal Fibula Kit, Wristar MultiAx Distal Radius Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 12, 2025 | K252959 | WRISTAR MultiAx Distal Radius Kit | HRS | Substantially Equivalent | Intrauma S.P.A | accessdata.fda.gov |
| September 1, 2023 | K230623 | KITE Distal Fibula Kit | HRS | Substantially Equivalent | Intrauma S.P.A | accessdata.fda.gov |
| July 19, 2021 | K201147 | Elos® Intramedullary Nailing System | HSB | Substantially Equivalent | Intrauma S.P.A | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Plate, Fixation, Bone
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Screw, Fixation, Bone
Updated November 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.