Last updated on June 2019

Clinical Evaluation of Fortilink TETRAfuse Interbody Fusion Device in Subjects With Degenerative Disc Disease


Brief description of study

This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.

Detailed Study Description

This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.

There will be 3 arms in the study, one for each configuration of the Fortilink IBF system (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and European Union (EU).

Clinical Study Identifier: NCT03761563

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Spine Institute of South Florida

Delray Beach, FL United States
3.42miles
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Florida Back Institute

Boca Raton, FL United States
7.31miles
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