Zavation Medical Products, LLC, receives FDA 510K Clearance for eZspand™ Lateral Cage as an addition to its eZspand™ Interbody System.
FLOWOOD, Miss., June 10, 2022 /PRNewswire/ — Zavation Medical Products (“Zavation” or the “Company”), an innovative designer and manufacturer of high-quality spinal implants, instruments, MIS procedural kits, and biologics headquartered in Flowood, MS, announced the FDA 510K Clearance of eZspand™ Lateral, an expandable lumbar interbody fusion device.
The eZspand™ Lateral, part of the Zavation eZspand™ Interbody System, features unmatched expandable precision paired with continual expansion to provide an optimized fit for each patient. This optimized fit allows for enhancement of structural stability and improved sagittal balance. eZspand™ Lateral does not require secondary locking, minimizing procedural steps. The cage has up to 15° lordosis and the ability to back fill with bone graft. Each implant expands to 6mm from the insertion height to create a large graft window that facilitates fusion. The benefits of continuous height adjustment, up to 6mm expansion paired with no secondary locking step, separate eZspand™ Lateral from its competitors.
Zavation’s market share and active surgeon base continues to rapidly grow given the Company’s ability to adapt to surgeon/patient needs, consistently upgrade its instruments, and engineer devices with incomparable simplicity and precision. Zavation’s sustained investment in research and development will further enhance its expandable technologies and accelerate market share and active surgeon base gains.
“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,” said Jeffrey Johnson, Chief Executive Officer. “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.”
INDICATIONS FOR USE
The Zavation eZspand™ Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand™ Interbody System implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.
The Zavation eZspand™ Interbody System implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.
ABOUT ZAVATION MEDICAL PRODUCTS, LLC.
Based in Flowood, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware and biologics covering key areas including cervical, thoracolumbar, interbody fusion, interventional spine, and minimally invasive surgery. Founded in 2012, Zavation has experienced exceptional growth and created a national network of numerous distributors across the United States. The Company has commercialized over 25 product families since inception. Zavation operates a newly constructed 75,000 square foot vertically integrated facility in Flowood, MS. To learn more information about Zavation and the Company’s suite of products, visit www.zavation.com.
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SOURCE Zavation Medical Products, LLC.
