Tuesday, December 24, 2019
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.
