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.

1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.