Atpac Medical, LLC
Country not established
- Devices
- 1
What Atpac Medical, LLC makes
Atpac Medical, LLC manufactures the PolyFuse NeuroBone, a medical device designed for cranial or facial bone reconstruction, featuring a biodegradable polymer scaffold that integrates with bone tissue over time.
The PolyFuse NeuroBone is classified as a Class II device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Polyfuse - Neurobone Ref K111018
510(k) 510(k)
Frequently asked questions
How many devices does Atpac Medical, LLC have in the registry?
The registry currently lists 1 device for Atpac Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Atpac Medical, LLC's devices?
Among its 1 most recently registered device, Atpac Medical, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Atpac Medical, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Atpac Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Atpac Medical, LLC in the registry?
The most recently registered devices listed for Atpac Medical, LLC include POLYFUSE - NEUROBONE.