Driskell Bioengineering
Country not established
- Devices
- 4
What Driskell Bioengineering makes
Driskell Bioengineering manufactures titanium-based orthopedic implant systems, including the DB Precision Implant System in 1000 and 2000 Series variants, some of which incorporate hydroxyapatite coating (HAC) for enhanced bone integration. These devices are designed for joint replacement surgeries, such as knee or hip arthroplasty, providing customizable components for surgical precision.
The company’s implant systems are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
Db Precision Implant System Ref K853788
510(k) 510(k)Db Precision Implant System, 2000 Series Ref K860982
510(k) 510(k)Db Precision Implant System, 2000 Series W/Hac Ref K875243
510(k) 510(k)Db Precision Implant System, 1000 Series W/Hac Ref K875242
510(k) 510(k)
Frequently asked questions
How many devices does Driskell Bioengineering have in the registry?
The registry currently lists 4 devices for Driskell Bioengineering. Devices recorded under merged duplicate company entries are counted once.
Which registries list Driskell Bioengineering's devices?
Among its 4 most recently registered devices, Driskell Bioengineering has devices listed in FDA 510(k) (4 devices).
What risk classes do Driskell Bioengineering's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Driskell Bioengineering's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Driskell Bioengineering in the registry?
The most recently registered devices listed for Driskell Bioengineering include DB PRECISION IMPLANT SYSTEM, DB PRECISION IMPLANT SYSTEM, 2000 SERIES, DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HAC and DB PRECISION IMPLANT SYSTEM, 1000 SERIES W/HAC.