Soteira, Inc.
Country not established
- Devices
- 1
What Soteira, Inc. makes
Soteira, Inc. manufactures the SHIELD Kyphoplasty System, a device used for vertebral augmentation to treat painful vertebral compression fractures, restoring spinal stability and reducing pain.
The SHIELD Kyphoplasty System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) clearance pathway. The company is based in the United States.
Catalogue
Shield Kyphoplasty System Ref K093477
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Soteira, Inc. have in the registry?
The registry currently lists 1 device for Soteira, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Soteira, Inc.'s devices?
Among its 1 most recently registered device, Soteira, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Soteira, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Soteira, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Soteira, Inc. in the registry?
The most recently registered devices listed for Soteira, Inc. include SHIELD KYPHOPLASTY SYSTEM.