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FDA 510(k)

Outlet Sacroiliac Joint Fusion System

K-Number: K181881 · 2018-10-03

ApplicantSij Surgical
Decision Date2018-10-03
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Outlet Sacroiliac Joint Fusion System is a medical device manufactured by Sij Surgical. It received FDA 510(k) clearance on 2018-10-03 under approval number K181881. 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 Outlet Sacroiliac Joint Fusion System?

Outlet Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2018-10-03. It is manufactured by Sij Surgical. The 510(k) number is K181881.

When was Outlet Sacroiliac Joint Fusion System approved by the FDA?

Outlet Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2018-10-03, under approval number K181881.

What company makes Outlet Sacroiliac Joint Fusion System?

Outlet Sacroiliac Joint Fusion System is manufactured by Sij Surgical.

What is the FDA product code for Outlet Sacroiliac Joint Fusion System?

The FDA product code for Outlet Sacroiliac Joint Fusion System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07609511 Magnet System Gastric Outlet Obstruction Study NOT_YET_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 37365092 Comparison of the international regulations for medical devices-USA versus Europe. Injury (2023) PMID: 34249562 Trends in Diagnosis and Treatment of Sacroiliac Joint Pathology Over the Past 10 Years: Review of Scientific Evidence for New Devices for Sacroiliac Joint Fusion. Cureus (2021)

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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