SI-BONE Earns FDA Clearance for Changes to iFuse System

June 13, 2016

SI-BONE has nabbed FDA clearance for an updated indication to its iFuse implant addressing improvements to pain, function and quality of life.

The modification was based on three clinical trials evaluating the system’s safety and efficacy.

The device, originally cleared in November 2008, currently is used in fusion procedures for certain disorders of the sacroiliac joint, according to the San Jose-Calif.-based company. — Anisa Jibrell

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