Spinal Elements receives FDA 510(k) clearance for interspinous process device
Spinal Elements announced it has received FDA 510(k) clearance to market an interspinous process device.
According to a company press release, the device features enhancements that make the device more accommodating to patient anatomy and streamline the surgical procedure. The interspinous process device may be implanted via minimally invasive surgery or through conventional techniques. It may also be used for either superspinous ligament sparing or sacrificing approaches.
“This clearance is another indicator of our relentless pursuit of solutions demanded by our surgeon customers,” Todd Andres, chief executive officer and cofounder of Spinal Elements, said in the release. “This device addresses part of our strategy to become the first choice of surgeons in both hospital and outpatient surgery settings.”
Spinal Elements plans to initiate clinical procedures with the devices later this year, with an initial product launch in early 2017.