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FDA 510(k)

UNITY Sacroiliac Joint Fixation System

K-Number: K222448 · 2022-10-13

ApplicantDio Medical Corporation
Decision Date2022-10-13
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITY Sacroiliac Joint Fixation System is a medical device manufactured by Dio Medical Corporation. It received FDA 510(k) clearance on 2022-10-13 under approval number K222448. 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 UNITY Sacroiliac Joint Fixation System?

UNITY Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Dio Medical Corporation. The 510(k) number is K222448.

When was UNITY Sacroiliac Joint Fixation System approved by the FDA?

UNITY Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2022-10-13, under approval number K222448.

What company makes UNITY Sacroiliac Joint Fixation System?

UNITY Sacroiliac Joint Fixation System is manufactured by Dio Medical Corporation.

What is the FDA product code for UNITY Sacroiliac Joint Fixation System?

The FDA product code for UNITY 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 Dio Medical Corporation

K222415Rexious Spinal Fixation System K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System K222515FaSet 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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