Devices Orthopaedic Neurosurgery FDA

 News Release - June 28, 2018

Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology(TM) Hyperlordotic ALIF Interbody Spinal Fusion System

REDLANDS, Calif. and AUSTIN, Texas, June 28, 2018 -- (Healthcare Sales & Marketing Network) -- Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® SA Hyperlordotic ALIF Interbody Spinal Fusion System.

Tesera SA is a porous titanium stand-alone anterior lumbar interbody fusion system featuring a four-screw design and a locking cover plate to prevent screw backout. Implants are now available in 7°, 12°, 17°, 22° and 28° lordotic angles with varying heights and footprints for proper intervertebral height and lordosis restoration, along with advanced instrumentation designed to reduce operative steps.

All Tesera implants utilize additive manufacturing (3D printing) and a proprietary, patent-pending design to create a roughened, highly porous surface structure that allows for bone attachment and in-growth to the implant, maximizing strength, stability and biologic fixation. Renovis now offers multiple 3D-printed, porous titanium implant systems for interbody spinal fusion, including anterior cervical, anterior lumbar, as well as posterior lumbar options.

For more information on the Tesera porous structure, visit www.teseratrabeculartechnology.com, or visit the company website to learn about our systems for spine, total joint replacement and trauma applications at www.renovis-surgical.com.

About Renovis Surgical

Renovis Surgical Technologies, Inc. was founded in 2009 with the mission to be a leading manufacturer of advanced medical devices, striving to continuously exceed customer expectations in service, quality, reliability, and value. The company is headquartered in Redlands, California, with engineering & manufacturing operations in Austin, Texas.

For additional information on the Company, please visit www.renovis-surgical.com.

Source: Renovis Surgical Technologies

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