Life Spine Announces FDA 510(k) of the Steerable PLATEAU® Ti System
HUNTLEY, Ill.--(BUSINESS WIRE)--Feb 6, 2020--
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the Steerable PLATEAU Ti System.
“The Steerable PLATEAU Ti System is one of many novel systems slated to join our Micro Invasive portfolio this year,” said Michael Butler, President and CEO of Life Spine. “These launches are testimony to our continued dedication in supporting less invasive procedures. The Steerable PLATEAU Ti System allows for controlled delivery upon insertion to facilitate positioning in the anterior portion of the disc space and features a curved design to match patient anatomy and maximize endplate coverage. Additionally, the spacer was designed to restore patient sagittal balance with lordotic options of 7° and 12°.”
The Steerable PLATEAU Ti System is available in lengths of 28mm and 32mm and heights ranging from 9mm-14mm in 1mm increments. The system also features Life Spine’s proprietary OSSEO-LOC ™ Surface architecture of 400-600 micron porosity. The Steerable PLATEAU Ti System is complemented by Life Spine’s CENTRIC ® -T Pedicle-Based Retractor System and the AVATAR ® MIS Spinal Fixation System.
About Life Spine
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com and/or https://www.micro-invasive.com.
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CONTACT: Mr. Omar Faruqi
Chief Financial Officer
KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS
INDUSTRY KEYWORD: BIOTECHNOLOGY FDA SURGERY MEDICAL DEVICES HEALTH
SOURCE: Life Spine
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PUB: 02/06/2020 03:19 PM/DISC: 02/06/2020 03:19 PM