Life Spine has announced that the US 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 realise significant gains in the thoracolumbar fusion space."
