Zavation Medical Products, LLC, Receives 510K Clearance from the FDA for Varisync™ Anterior Cervical Plate and Spacer System to Complement its Cervical Spine Portfolio
FLOWOOD, Miss., August 18, 2022 /PRNewswire/ — Zavation Medical Products (“Zavation” or the “Company”), an innovative designer and manufacturer of high-quality spinal implants, instruments, MIS procedure kits and biologics, headquartered in in Flowood, MS, announced FDA 510K clearance of Varisync™, a cervical intervertebral fusion device.
Varisync™, the newest addition to Zavation’s cervical spine portfolio, has been tested and approved for independent and synchronized use of its plate and spacer components. This allows Zavation partner surgeons to use these plate and spacer options together as a system or to pair individual components with one of Zavation’s existing cervical portfolio options. The Varisync™ plate has been carefully designed and has attributes that include visual and tactile lock confirmation, ideal screw angulation, multiple insertion devices, and optimal spacer placement in the disc space.
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 improve its technologies and accelerate market share and base earnings of active surgeons.
“Our product development team’s dedication to creatively blending simplicity and precision into robust product design has produced a product that we believe is the new benchmark in facilitating patient fusion in the setting of ‘a transparent and streamlined process,’ said Jeffrey Johnson, CEO. “With the many interbody offerings offered by Zavation, it makes sense that we would develop a device that allows surgeons to easily integrate and place a plate and spacer combination of their choice.” This product is an example of Zavation’s commitment to offering innovative and differentiated products in conjunction with market-leading customer service to better serve our surgeons and distributor network.”
INDICATIONS FOR USE
The VariSync™ plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative disc disease (as defined by neck pain of disc origin with disc degeneration confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), non-union, anterior fusion failure, spondylolisthesis and spinal stenosis.
The VariSync™ spacer is an interbody fusion device intended for use in mature skeletal patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as disc pain with disc degeneration confirmed by history and radiographic studies. These patients must be skeletally mature and have had at least six (6) weeks of non-operative treatment. The VariSync™ spacer should be filled with autograft or allogeneic bone graft consisting of cancellous and/or corticocellous bone graft in skeletally mature patients. These devices are intended for use with an additional fixation such as the Zavation VariSync™ Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync™ plate, the assembly mirrors the indications of the VariSync™ spacer, with the VariSync™ plate serving as an additional fixation.
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 has 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 product line, visit www.zavation.com.
SOURCE Zavation Medical Products, LLC.