FDA 510(k)

TRELLIS SI Joint Fusion System

K-Number: K212962 · 2022-04-11

Decision Date2022-04-11

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRELLIS SI Joint Fusion System is a medical device manufactured by Orthofundamentals, LLC. It received FDA 510(k) clearance on 2022-04-11 under approval number K212962. 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 TRELLIS SI Joint Fusion System?

TRELLIS SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Orthofundamentals, LLC. The 510(k) number is K212962.

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

TRELLIS SI Joint Fusion System received FDA 510(k) clearance on 2022-04-11, under approval number K212962.

What company makes TRELLIS SI Joint Fusion System?

TRELLIS SI Joint Fusion System is manufactured by Orthofundamentals, LLC.

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

The FDA product code for TRELLIS 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)

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.