Yahoo · Sep 28, 2026
SI-BONE Receives FDA 510(k) Clearance for iFuse Granite Onyx™, Extending Its Compromised Bone Franchise Beyond the Pelvis
FDA Breakthrough Device Designated (BDD) platform engineered for durable fixation in low density boneSANTA CLARA, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), the global leader in developing procedural solutions to address clinical challenges associated with compromised bone, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the iFuse Granite Onyx System (Onyx). This is SI-BONE’s first product addressing the problem of compromised bone which

