Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 26, 2018
Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion SystemREDLANDS, Calif. and AUSTIN, Texas, Sept. 26, 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® X Lateral Interbody Fusion System.
Tesera X is the latest product to utilize Renovis' proprietary 3D-printed porous architecture, which is made using additively manufactured titanium alloy, and features a low modulus, load-sharing design with a randomized pore structure to mimic cancellous bone. A 550-micron average pore size and 68% porosity combined with micro-surface roughness within the structure makes for an ideal environment for bone ongrowth and ingrowth.
Tesera X completes Renovis' 3D-printed titanium interbody product portfolio, which also includes implants for ALIF, TLIF, PLIF, ACDF, and standalones. The company is hoping to take advantage of the recent consolidations in the spine market.
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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