Chrysalis Intelligence · Sponsors · SI-BONE, Inc.

SI-BONE, Inc.

Santa Clara, CA, US · 15 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
15
2020-03-31 → 2026-02-11
Last 12 months
3
Product codes
2
Most recent
2026-02-11
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OUR Sacroiliac Joint Fixation Class II Orthopedic 12 2026-02-11
OLO Orthopedic Stereotaxic Instrument Class II Neurology 3 2025-09-15
Filings

All 510(k) clearances (15)

Date K-number Device Code Class Specialty
2026-02-11 K253488 iFuse INTRA Ti™ Implant System OUR Class II Orthopedic
2025-10-09 K253094 iFuse Bedrock Granite Implant System OUR Class II Orthopedic
2025-09-15 K251780 iGPS Navigation Instruments OLO Class II Neurology
2024-08-19 K241504 iFuse TORQ TNT™ Implant System OUR Class II Orthopedic
2024-07-02 K241574 iFuse TORQ® Implant System OUR Class II Orthopedic
2024-02-23 K232800 Navigation Tracking Instruments OLO Class II Neurology
2024-01-26 K233508 iFuse Bedrock Granite® Implant System OUR Class II Orthopedic
2023-06-30 K231689 iFuse TORQ® Implant System OUR Class II Orthopedic
2022-12-22 K222774 iFuse Bedrock Granite® Implant System OUR Class II Orthopedic
2022-09-29 K222605 iFuse TORQ® Implant System OUR Class II Orthopedic
2022-06-10 K213667 iFuse-TORQ® Implant System OUR Class II Orthopedic
2022-05-26 K220195 iFuse Bedrock Granite™ Implant System OUR Class II Orthopedic
2021-02-25 K203247 iFuse-TORQ™ Implant System OUR Class II Orthopedic
2020-11-09 K203110 iFuse Implant System - iFuse Navigation OLO Class II Neurology
2020-03-31 K193524 SI-BONE iFuse Implant System® OUR Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence