RegulatorySpine

Life Spine Announces FDA 510(k) Clearance of the Titanium Stand-Alone ALIF Spacer System

December 23, 2019

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 Titanium Stand-Alone ALIF Spacer System.

“This system clearance is the capstone on a year of incredible product launches for us,” said Michael Butler, President and CEO of Life Spine. “The system boasts our OSSEO-LOC surface technology, a comprehensive offering of footprints, an integrated cam locking mechanism and the option to utilize robust barbs in lieu of screws if supplemental fixation is employed.”

The Titanium Stand-Alone ALIF System comes in footprints of 34mm x 24mm, 38mm x 28mm and 42mm x 30mm. Additionally, there are three lordotic options of 6°, 12° and 18° and heights ranging from 11-17mm. The screws allow for stand-alone use of the system and offer angulation up to 45°. However, the system can also be utilized with barbs, which feature teeth and a threaded head designed for ease of removal, if supplemental fixation is utilized. The system will join Life Spine’s family of Dyna-Link Stand-Alone Spacers and is complemented by simplified instrumentation and Life Spine’s ALIF Disc Prep Instruments.

This 510(k) is the seventh in 2019 for Life Spine and their 88th since inception in 2004. Clearances in 2019 have included the CENTERLINE® Modular Thoracolumbar Fixation System, the LONGBOW® Titanium Expandable Spacer System and extended approvals for the PROLIFT® Expandable Spacer System in new narrow and lateral offerings.

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

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Chris J. Stewart

Chris currently serves as Chief Executive Officer of Surgio Health as well as COO at Ortho Spine Partners. 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 solve real problems that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help drive 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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