Aap GmbH and Co. Betriebs KG
GermanyFDA applicant, unverified
- Devices
- 1
What Aap GmbH and Co. Betriebs KG makes
Aap GmbH and Co. Betriebs KG manufactures the BIORIGID NAIL TIBIA, a medical device designed for internal fixation of tibial fractures. This intramedullary nail is intended to stabilize long bone fractures and aid in the healing process through rigid internal support.
The BIORIGID NAIL TIBIA is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Biorigid Nail Tibia Ref K970013
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aap GmbH and Co. Betriebs KG have in the registry?
The registry currently lists 1 device for Aap GmbH and Co. Betriebs KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aap GmbH and Co. Betriebs KG's devices?
Among its 1 most recently registered device, Aap GmbH and Co. Betriebs KG has devices listed in FDA 510(k) (1 device).
What risk classes do Aap GmbH and Co. Betriebs KG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Aap GmbH and Co. Betriebs KG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aap GmbH and Co. Betriebs KG in the registry?
The most recently registered devices listed for Aap GmbH and Co. Betriebs KG include BIORIGID NAIL TIBIA.