Business Wire04.29.20
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, has received clearance from the U.S. Food & Drug Administration (FDA) to market implant and instrument additions to the ARx Spinal System.
“The additions to the ARx Spinal System will allow us to provide surgeons with the tools to accommodate a larger range of complex and deformity spinal procedures,” said Rich Mueller, chief operating officer for Life Spine. “The ARx Spinal System is designed to advance the treatment for spinal deformity patients with a range of unique spinal implants and intuitive instrumentation which is consistently being enhanced by our research and development team to meet patient needs.”
ARx is Life Spine’s fourth FDA 510(k) clearance in 2020 with 92 total since inception. The system is complemented by the PROLIFT Expandable System and can be utilized with the SOLSTICE OCT System.
In February and early March, Life Spine received FDA clearance to market the Steerable PLATEAU Ti System and Lateral PROLIFT Expandable System, respectively. The company also announced at time its intention to launch 20 new products, including six Micro Invasive Expandables, in 2020. It is not clear whether the global coronavirus pandemic has impacted the launch of those new products.
In late March, the company announced that it was partnering with Gizmo Medical on a production quantity of surgical masks and gowns and identifying ways to scale other medical equipment to meet the growing and urgent demand in the United States.
“Life Spine and Gizmo have moved to leverage our long-standing relationship and come together to help meet an imminent need for personal protective equipment and medical equipment,” Michael Butler, president and CEO of Life Spine, said. “Production is underway and we look forward to supporting those who are on the front lines and faced with potential shortages.”
“The additions to the ARx Spinal System will allow us to provide surgeons with the tools to accommodate a larger range of complex and deformity spinal procedures,” said Rich Mueller, chief operating officer for Life Spine. “The ARx Spinal System is designed to advance the treatment for spinal deformity patients with a range of unique spinal implants and intuitive instrumentation which is consistently being enhanced by our research and development team to meet patient needs.”
ARx is Life Spine’s fourth FDA 510(k) clearance in 2020 with 92 total since inception. The system is complemented by the PROLIFT Expandable System and can be utilized with the SOLSTICE OCT System.
In February and early March, Life Spine received FDA clearance to market the Steerable PLATEAU Ti System and Lateral PROLIFT Expandable System, respectively. The company also announced at time its intention to launch 20 new products, including six Micro Invasive Expandables, in 2020. It is not clear whether the global coronavirus pandemic has impacted the launch of those new products.
In late March, the company announced that it was partnering with Gizmo Medical on a production quantity of surgical masks and gowns and identifying ways to scale other medical equipment to meet the growing and urgent demand in the United States.
“Life Spine and Gizmo have moved to leverage our long-standing relationship and come together to help meet an imminent need for personal protective equipment and medical equipment,” Michael Butler, president and CEO of Life Spine, said. “Production is underway and we look forward to supporting those who are on the front lines and faced with potential shortages.”