Biofusion Medical is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biofusion Medical - FDA 510(k) Cleared Devices
Recent clearances: SI-Restore Sacroiliac Joint Fixation System, SI-Restore® Sacroiliac Joint Fixation System
2
Total
2
Cleared
0
Denied
Biofusion Medical has 2 FDA 510(k) cleared medical devices. Based in Austin, US.
Historical record: 2 cleared submissions from 2019 to 2020. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Biofusion Medical Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Surgop Support as regulatory consultant.
FDA 510(k) Regulatory Record - Biofusion Medical
2 devices