Innovasive granted FDA clearance for DualX expanding interbody spinal device

In a recent press release, Innovasive, a privately-held spinal device company, focused on developing and commercializing minimally-invasive, announced that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their DualX technology, a titanium, dual expanding, interbody device for spinal fusion procedures in the lumbar spine.

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“DualX is a unique expandable interbody that expands in two independent directions,” explained Andy Choi, Chief Executive Officer, Innovasive, Inc. “First, it expands laterally to provide a wide base for stability and spinal support. DualX then expands vertically with lordosis to aide in the restoration of sagittal alignment of the lumbar spine.”

The DualX technology is comprised of a family of titanium expandable interbody devices designed to be used in transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF) and lateral lumbar interbody fusion (LLIF) spinal procedures. The product portfolio contains varying footprints, heights and degrees of lordosis with post-expansion bone grafting to provide a customized anatomical fit for a clinically successful fusion environment.

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