Biofusion Medical
United Statesfrom the FDA registration address FDA FEI 3015422154
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Biofusion Medical makes
Biofusion Medical manufactures the SI-Restore Sacroiliac Joint Fixation System, a device designed for fixation of the sacroiliac joint.
The SI-Restore system is classified as a Class II medical device and is listed in the FDA 510(k) registry. Biofusion Medical is based in the United States.
Catalogue
SI-Restore Sacroiliac Joint Fixation System Ref K200868
Regimes: 510(k) Registry: 510(k)SI-Restore® Sacroiliac Joint Fixation System Ref K182919
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3015422154
- Address
- 4020 S Industrial Drive, Austin, TX, 78744
Frequently asked questions
How many devices does Biofusion Medical have in the registry?
The registry currently lists 2 devices for Biofusion Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biofusion Medical's devices?
Among its 2 most recently registered devices, Biofusion Medical has devices listed in FDA 510(k) (2 devices).
What risk classes do Biofusion Medical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biofusion Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biofusion Medical in the registry?
The most recently registered devices listed for Biofusion Medical include SI-Restore Sacroiliac Joint Fixation System and SI-Restore® Sacroiliac Joint Fixation System.