Spinal Elements has received 510(k) clearance from the USA Food and Drug Administration (FDA) to market an interspinous process device.
Spinal Elements’ device includes enhancements designed to make the device more accommodating to patient anatomy while streamlining the surgical procedure. The surgeon should be able to intraoperatively choose the approach that best suits their needs and the needs of their patients. The device may be implanted with minimally-invasive surgical techniques or conventional techniques and may be used in superspinous ligament sparing or sacrificing approaches.
The company plans to begin clinical procedures with the interspinous process devices later this year with an initial launch in early 2017.