RegulatorySpine

Life Spine Announces FDA 510(k) of the Steerable PLATEAU® Ti System

February 06, 2020

HUNTLEY, Ill.–(BUSINESS WIRE)–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.

Contacts

Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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