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FDA 510(k)

T-FIX™ 3DSI Joint Fusion System

K-Number: K230689 · 2023-04-05

ApplicantCutting Edge Spine, LLC
Decision Date2023-04-05
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T-FIX™ 3DSI Joint Fusion System is a medical device manufactured by Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2023-04-05 under approval number K230689. 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 T-FIX™ 3DSI Joint Fusion System?

T-FIX™ 3DSI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-04-05. It is manufactured by Cutting Edge Spine, LLC. The 510(k) number is K230689.

When was T-FIX™ 3DSI Joint Fusion System approved by the FDA?

T-FIX™ 3DSI Joint Fusion System received FDA 510(k) clearance on 2023-04-05, under approval number K230689.

What company makes T-FIX™ 3DSI Joint Fusion System?

T-FIX™ 3DSI Joint Fusion System is manufactured by Cutting Edge Spine, LLC.

What is the FDA product code for T-FIX™ 3DSI Joint Fusion System?

The FDA product code for T-FIX™ 3DSI 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) 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)

Other Devices by Cutting Edge Spine, LLC

K180674EVOL® ha-C Cervical Interbody Fusion System K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody System K190025EVOL® -SI Joint Fusion System K200991EVOL Spinal Interbody System K200552EVOS Lumbar Interbody System K192497EVOL ha - D Lateral Interbody Fusion System

View all 9 devices →

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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