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Wednesday, September 28, 2022

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Zavation Medical Products, LLC, receives FDA 510K Clearance for Varisync Anterior Cervical Plate and Spacer System As An Addition to its Cervical Spine Portfolio

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 Varisync™, a cervical intervertebral body fusion device.

Varisync, the most recent addition to the Zavation cervical spine portfolio, has been tested and approved for both the independent and synchronized use of its plate and spacer components. This allows Zavation’s surgeon partners to use these plate and spacer options together as a system or pair individual components with any of Zavation’s existing cervical portfolio options. The Varisync™ plate has been thoughtfully designed and boasts attributes that include visual and tactile confirmation of locks, ideal screw angulation, multiple insertion devices, and optimal spacer placement in the disc space.

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 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 a 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 the extensive interbody offerings that Zavation boasts, it only makes sense that we 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 best 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 discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The VariSync™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The VariSync™ Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental 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 takes on the indications of the VariSync™ Spacer, with the VariSync™ Plate acting as the supplemental fixation.

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