Life Spine has received FDA 510(k) marketing clearance for both the 'Dyna-Link' Spinal System and the 'Presidio' Spinal Plating System. The Dyna-Link system features a 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 a zero-step locking mechanism and utilize comprehensive instrumentation designed to reduce surgical steps and intra-operative complexity.
Michael Butler, president and CEO of Life Spine, said: “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.”
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to pre-marketing approval.
Hoffman Estates, Illinois-based Life Spine develops systems for spinal patients.