SI-BONE, Inc.
SI-BONE, Inc. holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026, with 1 FDA device recall on record.
Top product codes for SI-BONE, Inc.
FDA recalls by SI-BONE, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by SI-BONE, Inc.
- K262067 — iFuse Granite Onyx Implant System
- K253488 — iFuse INTRA Ti Implant System
- K253094 — iFuse Bedrock Granite Implant System
- K251780 — iGPS Navigation Instruments
- K241504 — iFuse TORQ TNT Implant System
- K241574 — iFuse TORQ® Implant System
- K232800 — Navigation Tracking Instruments
- K233508 — iFuse Bedrock Granite® Implant System
- K231689 — iFuse TORQ® Implant System
- K222774 — iFuse Bedrock Granite® Implant System
- K222605 — iFuse TORQ® Implant System
- K213667 — iFuse-TORQ® Implant System
- K220195 — iFuse Bedrock Granite Implant System
- K203247 — iFuse-TORQ Implant System
- K203110 — iFuse Implant System - iFuse Navigation
- K193524 — SI-BONE iFuse Implant System®
- K190230 — iFuse Implant System®
- K182983 — iFuse Implant System®
- K172268 — iFuse Implant System- iFuse Navigation
- K162733 — iFuse Implant System® - iFuse-3D implant
- K161893 — Neuromonitoring Kit
- K160652 — iFUSE Implant System
- K152681 — iFuse Implant System(R)
- K151718 — iFuse Implant System
- K150875 — iFuse Implant System
- K150714 — SI-BONE iFuse Implant System
- K141049 — IFUSE IMPLANT SYSTEM
- K131405 — IFUSE IMPLANT SYSTEM
- K123850 — IFUSE IMPLANT SYSTEM
- K122074 — IFUSE IMPLANT SYSTEM
- K110838 — IFUSE IMPLANT SYSTEM
- K092375 — MODIFICATION TO SI JOINT FUSION SYSTEM
- K080398 — SI JOINT FUSION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.