Orion Biotech, Inc.
TaiwanFDA applicant, unverified
- Devices
- 1
What Orion Biotech, Inc. makes
Orion Biotech, Inc. manufactures the ORION Spinal System, a device designed for spinal surgical applications, including fixation and stabilization of the spine.
The ORION Spinal System is classified as a Class II medical device in the U.S. and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
ORION Spinal System Ref K190600
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orion Biotech, Inc. have in the registry?
The registry currently lists 1 device for Orion Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orion Biotech, Inc.'s devices?
Among its 1 most recently registered device, Orion Biotech, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Orion Biotech, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Orion Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orion Biotech, Inc. in the registry?
The most recently registered devices listed for Orion Biotech, Inc. include ORION Spinal System.