Wittenstein Intens GmbH
GermanyFDA applicant, unverified
- Devices
- 187
What Wittenstein Intens GmbH makes
Wittenstein Intens GmbH manufactures the FITBONE TAA, a medical device designed for total ankle arthroplasty (replacement surgery). This product is intended to restore ankle joint function in patients with severe osteoarthritis or degenerative joint disease.
The FITBONE TAA is classified as a Class II device under regulatory frameworks and has been submitted for clearance via the FDA’s 510(k) pathway. The company operates from the United States, adhering to applicable medical device regulations in that jurisdiction.
Catalogue
Search and filter all 187 devicesShowing 1-50 of 187
Company details
- DUNS number
- 315887799
- [email protected]
- Phone
- +4979314930
Frequently asked questions
How many devices does Wittenstein Intens GmbH have in the registry?
The registry currently lists 187 devices for Wittenstein Intens GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wittenstein Intens GmbH's devices?
Among its 50 most recently registered devices, Wittenstein Intens GmbH has devices listed in FDA GUDID (50 devices).
What risk classes do Wittenstein Intens GmbH's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Wittenstein Intens GmbH's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wittenstein Intens GmbH in the registry?
The most recently registered devices listed for Wittenstein Intens GmbH include FITBONE® TAA1180-F-245, FITBONE® REAM D12.0 L100 L480 FC, FITBONE® CEl 115V and FITBONE® CEl 120V.