Treu-Instrumente GmbH
GermanyFDA applicant, unverified
- Devices
- 26
What Treu-Instrumente GmbH makes
Treu-Instrumente GmbH manufactures non-bioabsorbable, non-sterile orthopaedic bone screws designed for surgical fixation applications. The product line includes multiple variants of the TREU screw, which are intended for use in bone stabilization procedures.
These devices fall under FDA Class II regulation and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The company operates within the United States regulatory framework.
Catalogue
Search and filter all 26 devicesCompany details
- DUNS number
- 341154493
- [email protected]
- Phone
- +4974679476730
Frequently asked questions
How many devices does Treu-Instrumente GmbH have in the registry?
The registry currently lists 26 devices for Treu-Instrumente GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Treu-Instrumente GmbH's devices?
Among its 26 most recently registered devices, Treu-Instrumente GmbH has devices listed in FDA 510(k) (1 device) and FDA GUDID (25 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Treu-Instrumente GmbH's devices fall under?
Among its 26 most recently registered devices, the classes recorded for Treu-Instrumente GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Treu-Instrumente GmbH in the registry?
The most recently registered devices listed for Treu-Instrumente GmbH include TREU 7-1405, TREU 8-09931, TREU 8-11170 and TREU 8-09761.