Si-Bone, Inc. (other, Santa Clara, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument
Si-Bone, Inc. (Santa Clara, California): 2 new FDA device listings, incl. orthopedic stereotaxic instrument. Its amount of 2 is above the median of 1 (69th percentile). Dated 38 days ago, it serves as a historical benchmark. Score 60/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (284 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-28
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Si-Bone, Inc. and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Si-Bone, Inc.'s amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Si-Bone, Inc. in Santa Clara, California?
Si-Bone, Inc. (Santa Clara, CA), a other, added 2 FDA device listings on 2026-09-28.
How does Si-Bone, Inc. compare to other California DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 38 days old, still within a typical 45-day follow-up window.
Si-Bone, Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Si-Bone, Inc. | Santa Clara, CA | 2 | 69th | 2026-09-28 |
| Integrity United Inc Dba Costcare | Anaheim, CA | 3 | 77th | 2026-09-08 |
| Karl Storz Endoscopy-America, Inc. | El Segundo, CA | 15 | 96th | 2026-09-28 |
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DeviceEstablishmentPulse: Other DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in California
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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.