# Si-Bone, Inc. (other, Santa Clara, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument

**Score:** 60/100

| Field | Value |
|---|---|
| Establishment | Si-Bone, Inc. |
| Owner / operator | SI-BONE, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Santa Clara, CA, US |
| New listings | 2 |
| Devices | Orthopedic Stereotaxic Instrument; Thoracolumbosacral Pedicle Screw System |
| Product codes | OLO, NKB |
| Device classes | Class II |
| Medical specialties | Neurology, Orthopedic |
| Brand names | iFuse Granite Onyx Implant System; iFuse Granite Onyx Navigation Instruments(intended for use with Onyx Implant System and Medtronic StealthStation System); iFuse Granite Onyx Navigation Instruments(intended for use with Onyx Implant System and ExcelsiusGPS System) |
| First new listing | 2026-09-28 |
| Latest new listing | 2026-09-28 |
| FDA registration number | 3007700286 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.