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