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SI-BONE, Inc.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories3
Latest Approval2026-02-11
TypeNumberDevice NameCodeDate
510(k) K253488 iFuse INTRA Ti™ Implant System OUR 2026-02-11 View
510(k) K253094 iFuse Bedrock Granite Implant System OUR 2025-10-09 View
510(k) K251780 iGPS Navigation Instruments OLO 2025-09-15 View
510(k) K241504 iFuse TORQ TNT™ Implant System OUR 2024-08-19 View
510(k) K241574 iFuse TORQ® Implant System OUR 2024-07-02 View
510(k) K232800 Navigation Tracking Instruments OLO 2024-02-23 View
510(k) K233508 iFuse Bedrock Granite® Implant System OUR 2024-01-26 View
510(k) K231689 iFuse TORQ® Implant System OUR 2023-06-30 View
510(k) K222774 iFuse Bedrock Granite® Implant System OUR 2022-12-22 View
510(k) K222605 iFuse TORQ® Implant System OUR 2022-09-29 View
510(k) K213667 iFuse-TORQ® Implant System OUR 2022-06-10 View
510(k) K220195 iFuse Bedrock Granite™ Implant System OUR 2022-05-26 View
510(k) K203247 iFuse-TORQ™ Implant System OUR 2021-02-25 View
510(k) K203110 iFuse Implant System - iFuse Navigation OLO 2020-11-09 View
510(k) K193524 SI-BONE iFuse Implant System® OUR 2020-03-31 View
510(k) K190230 iFuse Implant System® OUR 2019-04-03 View
510(k) K182983 iFuse Implant System® OUR 2018-11-27 View
510(k) K172268 iFuse Implant System- iFuse Navigation OLO 2017-10-31 View
510(k) K162733 iFuse Implant System® - iFuse-3D implant OUR 2017-03-10 View
510(k) K161893 Neuromonitoring Kit PDQ 2016-10-18 View
510(k) K160652 iFUSE Implant System OUR 2016-06-03 View
510(k) K152681 iFuse Implant System(R) OUR 2016-03-01 View
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