Zavation Medical Products LLC has announced FDA 510(k) clearance of its eZspand Lateral, an expandable lumbar interbody fusion device, according to a press release.
The eZspand Lateral device is an addition to Zavation’s eZspand interbody system, which is indicated for use with autogenous bone graft in spinal fusion procedures in skeletally mature patients who have had 6 months of nonoperative treatment, according to the release.
“Our product development team’s dedication to creatively blending simplicity and precision in a robust product design has produced an expandable product that we believe is the new gold standard in facilitating patient fusion in a seamless and simplified procedure,” Jeffrey Johnson, CEO of Zavation Medical Products, said in the release. “With restoration of alignment being of critical importance, the eZspand Lateral was developed to help surgeons address stability and sagittal alignment, while maximizing lordotic correction. This product is an example of Zavation’s commitment to offering innovative and differentiated products in conjunction with market-leading customer service to best serve our surgeons and distributor network,” Johnson said.