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Spinal Frontiers · Regulatory Watch · FDA decision

SI-BONE clears iFuse Granite Onyx for fixation beyond the pelvis

FDA decision · SI-BONE

23 September 2026

SI-BONE's Granite Onyx system was cleared under the pedicle screw product code, which trade press reports as the company's first fusion implant aimed at compromised bone outside the pelvis.

Type
FDA decision
Company
SI-BONE
Device
iFuse Granite Onyx Implant System
Date
23 September 2026
Jurisdiction
US
Classification
510(k) K262067 (NKB; OLO)
Source
FDA 510(k) database

Official source →Source checked

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