Zavation Medical Products, LLC, receives 510K clearance from the FDA for the eZspand™ Lateral Cage to complement its eZspand™ Interbody System.
The Lateral eZspand™, part of the Zavation eZspand™ interbody system, offers unparalleled stretch precision combined with continuous expansion to provide an optimized fit for each patient. This optimized fit allows for improved structural stability and better sagittal balance. eZspand™ Lateral does not require secondary locking, minimizing procedural steps. The cage has a lordosis of up to 15° and the ability to backfill with bone grafting. Each implant extends up to 6mm from insertion height to create a large graft window that facilitates fusion. The benefits of continuous height adjustment, up to 6mm of expansion combined with the absence of a secondary locking step, separates eZspand™ Lateral from its competitors.
Zavation’s market share and active surgeon base continues to grow rapidly given the company’s ability to adapt to surgeon/patient needs, constantly upgrade its instruments and design devices with simplicity. and unparalleled precision. Zavation’s continued investment in research and development will further enhance its expandable technologies and accelerate market share and base earnings of active surgeons.
“Our product development team’s dedication to creatively combining simplicity and precision in a robust product design has produced a scalable product that we believe is the new benchmark in facilitating patient fusion in the setting.” transparent and streamlined process,” said Jeffrey Johnson, CEO. “As alignment restoration is of critical importance, the eZspand™ Lateral was developed to help surgeons manage stability and sagittal alignment, while maximizing lordotic correction. This product is an example of the Zavation’s commitment to deliver innovative and differentiated products in conjunction with a market-leading customer to best serve our surgeons and distributor network.”
INDICATIONS FOR USE
Zavation eZspand™ Interbody System Implants are indicated for spinal fusion procedures for use with autogenous bone grafting in skeletally mature patients. Zavation eZspand™ Interbody System Implants are intended for use at contiguous single or bi-level in the lumbar spine, from L2 through S1, for the treatment of degenerative disc disease (DDD) with spondylolisthesis up to Grade I. DDD is defined as low back pain of disc origin with disc degeneration confirmed by history and radiographic studies. The device is intended for use in patients who have had six months of non-operative treatment.
Zavation eZspand™ Interbody System Implants are intended for use with additional internal fixation appropriate to the implanted level, including the Zavation Spinal System.
ABOUT ZAVATION MEDICAL PRODUCTS, LLC.
Situated at 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 nationwide network of numerous distributors across the United States. The Company has marketed more than 25 product families since its creation. Zavation operates a new 75,000 square foot vertically integrated facility in Flowood, MS. To learn more about Zavation and the company’s suite of products, visit www.zavation.com.
SOURCE Zavation Medical Products, LLC.