Biogeneration
Country not established
- Devices
- 2
What Biogeneration makes
Biogeneration manufactures bone void fillers and associated kits designed to support bone regeneration and structural integrity in orthopedic and trauma applications. The PROFUSION BONE VOID FILLER is intended for filling defects or gaps in bone, while the PROFUSION BONE VOID FILLER KIT includes supplementary materials for surgical use.
The company’s portfolio is regulated as Class II medical devices under FDA 510(k) clearance requirements. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Profusion Bone Void Filler Ref K973704
510(k) 510(k)Profusion Bone Void Filler Kit Ref K031838
510(k) 510(k)
Frequently asked questions
How many devices does Biogeneration have in the registry?
The registry currently lists 2 devices for Biogeneration. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biogeneration's devices?
Among its 2 most recently registered devices, Biogeneration has devices listed in FDA 510(k) (2 devices).
What risk classes do Biogeneration's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biogeneration's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biogeneration in the registry?
The most recently registered devices listed for Biogeneration include PROFUSION BONE VOID FILLER and PROFUSION BONE VOID FILLER KIT.