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FDA 510(k)

ZESPIN SI Joint Fusion System

K-Number: K223521 · 2023-01-20

ApplicantAegis Spine, Inc.
Decision Date2023-01-20
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZESPIN SI Joint Fusion System is a medical device manufactured by Aegis Spine, Inc.. It received FDA 510(k) clearance on 2023-01-20 under approval number K223521. 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 ZESPIN SI Joint Fusion System?

ZESPIN SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by Aegis Spine, Inc.. The 510(k) number is K223521.

When was ZESPIN SI Joint Fusion System approved by the FDA?

ZESPIN SI Joint Fusion System received FDA 510(k) clearance on 2023-01-20, under approval number K223521.

What company makes ZESPIN SI Joint Fusion System?

ZESPIN SI Joint Fusion System is manufactured by Aegis Spine, Inc..

What is the FDA product code for ZESPIN SI Joint Fusion System?

The FDA product code for ZESPIN SI 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 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 NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED

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)

Other Devices by Aegis Spine, Inc.

K203531XYPAN Expandable Lumbar Cage System K221719ABTross ALIF Expandable Cage System K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate 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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