HOFFMAN ESTATES, Ill., Jan. 28 /PRNewswire/ — Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to both the DYNA-LINK Spinal System and the PRESIDIO Spinal Plating System.
The DYNA-LINK system features a next-generation stand-alone device that accommodates both fixed and variable angle screws. The PRESIDIO system is a thoracolumbar plating system that features multiple types of low-profile implants. Both offerings incorporate an innovative, zero-step locking mechanism and utilize comprehensive instrumentation designed to reduce surgical steps and intra-operative complexity.
Michael S. Butler, Life Spine’s president and CEO stated, “These two approvals are a testament to our commitment to rapidly achieving regulatory approval while at the same time introducing best-in-class products. Furthermore, these products will allow us to realize significant gains in the thoracolumbar fusion space.”
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 Hoffman Estates, Illinois. For more information, please visithttp://www.lifespine.com.
SOURCE Life Spine