Devise Ortho, Inc.
Country not established
- Devices
- 1
What Devise Ortho, Inc. makes
Devise Ortho, Inc. manufactures the DRIVE RAIL SYSTEM, a spinal fixation device used in orthopedic surgery for stabilizing the spine during procedures such as fusion or correction of deformities.
The DRIVE RAIL SYSTEM is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Drive Rail System Ref K140822
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Devise Ortho, Inc. have in the registry?
The registry currently lists 1 device for Devise Ortho, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Devise Ortho, Inc.'s devices?
Among its 1 most recently registered device, Devise Ortho, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Devise Ortho, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Devise Ortho, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Devise Ortho, Inc. in the registry?
The most recently registered devices listed for Devise Ortho, Inc. include DRIVE RAIL SYSTEM.