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FDA 510(k)

SI-Restore® Sacroiliac Joint Fixation System

K-Number: K182919 · 2019-01-25

ApplicantBiofusion Medical
Decision Date2019-01-25
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI-Restore® Sacroiliac Joint Fixation System is a medical device manufactured by Biofusion Medical. It received FDA 510(k) clearance on 2019-01-25 under approval number K182919. 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-Restore® Sacroiliac Joint Fixation System?

SI-Restore® Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by Biofusion Medical. The 510(k) number is K182919.

When was SI-Restore® Sacroiliac Joint Fixation System approved by the FDA?

SI-Restore® Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2019-01-25, under approval number K182919.

What company makes SI-Restore® Sacroiliac Joint Fixation System?

SI-Restore® Sacroiliac Joint Fixation System is manufactured by Biofusion Medical.

What is the FDA product code for SI-Restore® Sacroiliac Joint Fixation System?

The FDA product code for SI-Restore® Sacroiliac Joint Fixation System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Biofusion Medical

K200868SI-Restore Sacroiliac Joint Fixation System

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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