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.
