Published on January 28, 2010 at 8:39 AM
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."
SOURCE Life Spine