Innovasive, Inc.
Country not established
- Devices
- 1
What Innovasive, Inc. makes
Innovasive, Inc. manufactures the DualX, a medical device designed for [specific clinical purpose implied by Class II—likely a moderate-risk product such as a surgical instrument, diagnostic tool, or implant-related device].
The DualX 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
DualX Ref K181397
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Innovasive, Inc. have in the registry?
The registry currently lists 1 device for Innovasive, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innovasive, Inc.'s devices?
Among its 1 most recently registered device, Innovasive, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Innovasive, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Innovasive, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innovasive, Inc. in the registry?
The most recently registered devices listed for Innovasive, Inc. include DualX.