Ortho8, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ortho8, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CIRCUL8 Connect DVT Prevention Device, Circul8 Pro, CIRCUL8 Luxe DVT Prevention Device
3
Total
3
Cleared
0
Denied
Ortho8, Inc. has 3 FDA 510(k) cleared medical devices. Based in Rocklin, US.
Last cleared in 2022. Active since 2021. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Ortho8, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Medtech Review, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Ortho8, Inc.
3 devices