Life Spine, a medical device company, has secured ten 510(k) clearances in 2018 for a total of 81 since their inception in 2004.


Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.

The 510(k)’s Life Spine received in 2018 cover a wide variety of procedures and pathologies.

Life Spine marketing and business development vice president Mariusz Knap said: “We pride ourselves on the ability to rapidly develop new and innovative technologies that have the potential to improve patient care and quality of life.

“This year, receiving ten 510(k) clearances will help us to maintain our position as an innovation powerhouse.”

One key 510(k) clearance that Life Spine secured in 2018 was for the SIMPACT® Sacroiliac Joint Fixation System.

SIMPACT is a novel sacroiliac screw that was designed to reduce procedural time, decrease trauma to the surrounding muscles and lessen recovery time by utilizing a minimally invasive approach. SIMPACT® features Life Spine’s proprietary OSSEO-LOC surface technology and a self-drilling and self-tapping design.

Another notable clearance for Life Spine in 2018 was the PLATEAU-LO Spacer System which is a PEEK interbody designed with an oblique lordosis to better suit patient anatomy.

The system’s “Insert and Rotate” design allows for restoration of disc height and sagittal alignment, even in severely collapsed disc spaces.

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.

Source: Company Press Release