Innovasive Gains FDA Clearance for DualX Expanding Interbody

By Julie A. Vetalice

Innovasive received FDA 510(k) clearance to market the DualX™ titanium dual expanding interbody device for lumbar fusion. The product will be available for implantation by year-end.

DualX can expand in two independent directions: laterally, then vertically with lordosis to support restoration of sagittal alignment. Designs address transforaminal, posterior and lateral lumbar interbody fusion procedures.

Innovasive is a portfolio company of IntuitiveX, a life science innovation incubator. 3/2019 update: Innovasive has rebranded as Amplify Surgical.

Source: Innovasive
Innovasive DualX Expanding Interbody - ORTHOFLASH

What do surgeons think of expandable designs? Learn the opinions of Michael Steinmetz, M.D., Robert S. Bray Jr., M.D. and Stephen H. Hochschuler, M.D.

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory