Roesys GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Roesys GmbH makes
Roesys GmbH manufactures the X TWIN SYSTEM, a medical device designed for specific orthopedic applications, including spinal fixation and stabilization procedures.
The X TWIN SYSTEM is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
X Twin System Ref K133496
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roesys GmbH have in the registry?
The registry currently lists 1 device for Roesys GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roesys GmbH's devices?
Among its 1 most recently registered device, Roesys GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Roesys GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Roesys GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roesys GmbH in the registry?
The most recently registered devices listed for Roesys GmbH include X TWIN SYSTEM.