FDA 510(k)

SILO TFX MIS Sacroiliac Joint Fixation System

K-Number: K221047 · 2022-10-03

Decision Date2022-10-03

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SILO TFX MIS Sacroiliac Joint Fixation System is a medical device manufactured by Aurora Spine, Inc.. It received FDA 510(k) clearance on 2022-10-03 under approval number K221047. 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 SILO TFX MIS Sacroiliac Joint Fixation System?

SILO TFX MIS Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-03. It is manufactured by Aurora Spine, Inc.. The 510(k) number is K221047.

When was SILO TFX MIS Sacroiliac Joint Fixation System approved by the FDA?

SILO TFX MIS Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2022-10-03, under approval number K221047.

What company makes SILO TFX MIS Sacroiliac Joint Fixation System?

SILO TFX MIS Sacroiliac Joint Fixation System is manufactured by Aurora Spine, Inc..

What is the FDA product code for SILO TFX MIS Sacroiliac Joint Fixation System?

The FDA product code for SILO TFX MIS 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 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 NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED

Other Devices by Aurora Spine, Inc.

K210521DEXA-C Cervical Interbody System K210325APOLLO Anterior Cervical Plate (ACP) System K221399ZIP MIS Interspinous Fusion System K220610SOLO-L

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

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