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FDA 510(k)

SI-BONE iFuse Implant System®

K-Number: K193524 · 2020-03-31

ApplicantSI-BONE, Inc.
Decision Date2020-03-31
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI-BONE iFuse Implant System® is a medical device manufactured by SI-BONE, Inc.. It received FDA 510(k) clearance on 2020-03-31 under approval number K193524. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI-BONE iFuse Implant System®?

SI-BONE iFuse Implant System® is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by SI-BONE, Inc.. The 510(k) number is K193524.

When was SI-BONE iFuse Implant System® approved by the FDA?

SI-BONE iFuse Implant System® received FDA 510(k) clearance on 2020-03-31, under approval number K193524.

What company makes SI-BONE iFuse Implant System®?

SI-BONE iFuse Implant System® is manufactured by SI-BONE, Inc..

What is the FDA product code for SI-BONE iFuse Implant System®?

The FDA product code for SI-BONE iFuse Implant System® is OUR.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by SI-BONE, Inc.

K161893Neuromonitoring Kit K160652iFUSE Implant System K152681iFuse Implant System(R) K172268iFuse Implant System- iFuse Navigation K162733iFuse Implant System® - iFuse-3D implant K182983iFuse Implant System®

View all 22 devices →

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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