— Press Release —
Redlands, CA / Austin, TX (December 7, 2010) – 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 S100™ Pedicle Screw System. This full-featured thoracolumbar pedicle screw and rod system is used to treat various degenerative conditions of the lumbar spine. A comprehensive offering of screw and rod diameters allows the surgeon to tailor the surgical construct to the specific needs of the patient. The top-loading, low-profile design eases assembly and helps avoid impingement with adjacent anatomy.
The rods are secured using a locking cap that features the patented Helical Flange® technology. This novel thread design creates a positive lock between the pedicle screw and the locking cap. Once engaged, the Helical Flange prevents post-operative loosening of the assembled implant construct, ensuring a secure support structure for the healing spinal fusion.
About Renovis Surgical
Renovis Surgical Technologies was founded in 2009 with the express mission of creating highest quality implants for orthopedics, spine and trauma, and delivering those implants to the healthcare marketplace at a value. The company is based in Redlands, California, and has engineering and manufacturing operations in Austin, Texas. Helical Flange® is a registered trademark of Jackson Group.
For additional information on the Company, please visit http://www.renovis-surgical.com.
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Media Contact: info@renovis-surgical.com, 909.557.2360