SI-BONE Receives FDA 510(k) Approval for Spinal Fusion System

MT newswire2026/09/28 21:24

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05:24 PM EDT, 09/28/2026 (MT Newswires) -- SI-BONE (SIBN) said late Monday it received a 510(k) clearance from the US Food and Drug Administration for the iFuse Granite Onyx system to treat screw loosening in spinal fusion procedures, especially in patients with low bone density. The system allows for rapid osseointegration and lower micromotion to aim for early fixation and reduced screw loosening, according to a statement.

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