Ionos GmbH & Co. KG
GermanyFDA applicant, unverified
- Devices
- 1
What Ionos GmbH & Co. KG makes
Ionos GmbH & Co. KG manufactures the IONOS® OSSICLE in 5mm and 7mm sizes, a device designed for middle ear ossicle reconstruction or replacement.
The IONOS® OSSICLE is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Ionos(R) Ossicle 5mm & 7mm Ref K911583
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ionos GmbH & Co. KG have in the registry?
The registry currently lists 1 device for Ionos GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ionos GmbH & Co. KG's devices?
Among its 1 most recently registered device, Ionos GmbH & Co. KG has devices listed in FDA 510(k) (1 device).
What risk classes do Ionos GmbH & Co. KG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ionos GmbH & Co. KG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ionos GmbH & Co. KG in the registry?
The most recently registered devices listed for Ionos GmbH & Co. KG include IONOS(R) OSSICLE 5MM & 7MM.