SI-BONE, Inc. - FDA 510(k) Cleared Devices

SI-BONE, Inc. has 32 FDA 510(k) cleared orthopedic devices. Based in Santa Clara, US.

Latest FDA clearance: Feb 2026. Active since 2008.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Domecus Consulting Services, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.