Life Spine Gains Ten FDA Nods in One Year

Life Spine, a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced that the company received ten 510(k) clearances in 2018 for a total of 81 since their inception in 2004. The 510(k)’s Life Spine received in 2018 cover a wide variety of procedures and pathologies.
 
“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. In 2018, receiving ten 510(k) clearances will help us to maintain our position as an innovation powerhouse,” said Mariusz Knap, vice president of marketing and business development for Life Spine.
 
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.