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SI-BONE, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253488iFuse INTRA Ti™ Implant SystemFebruary 11, 2026
K253094iFuse Bedrock Granite Implant SystemOctober 9, 2025
K251780iGPS Navigation InstrumentsSeptember 15, 2025
K241504iFuse TORQ TNT™ Implant SystemAugust 19, 2024
K241574iFuse TORQ® Implant SystemJuly 2, 2024
K232800Navigation Tracking InstrumentsFebruary 23, 2024
K233508iFuse Bedrock Granite® Implant SystemJanuary 26, 2024
K231689iFuse TORQ® Implant SystemJune 30, 2023
K222774iFuse Bedrock Granite® Implant SystemDecember 22, 2022
K222605iFuse TORQ® Implant SystemSeptember 29, 2022
K213667iFuse-TORQ® Implant SystemJune 10, 2022
K220195iFuse Bedrock Granite™ Implant SystemMay 26, 2022
K203247iFuse-TORQ™ Implant SystemFebruary 25, 2021
K203110iFuse Implant System - iFuse NavigationNovember 9, 2020
K193524SI-BONE iFuse Implant System®March 31, 2020
K190230iFuse Implant System®April 3, 2019
K182983iFuse Implant System®November 27, 2018
K172268iFuse Implant System- iFuse NavigationOctober 31, 2017
K162733iFuse Implant System® - iFuse-3D implantMarch 10, 2017
K161893Neuromonitoring KitOctober 18, 2016