Aurora Spine (OTCQB:ASAPF) announced that it received FDA 510(k) clearance for its SiLO TFX MIS sacroiliac joint fixation system.
In a news release, the company described SiLo TFX MIS as a patented and minimally invasive system.
The company designed SiLO TFX MIS for sacroiliac joint fusion. Its use includes conditions such as sacroiliac joint disruptions and degenerative sacroiliitis.
SiLO TFX MIS features a transfixing cone, an ilium screw, a sacrum screw and associated instrumentation. Aurora Spine designed the implants to transfix the sacrum and ilium, providing stability for bony fusion.
“We are pleased with our continued commercial momentum as we expand our footprint for providing differentiated surgical devices in the sacropelvic/sacroiliac space,” said Trent Northcutt, president and CEO of Aurora Spine. “We will make meaningful investments in our sales force and physician training, which we believe will enable us to further capitalize on the growth in outpatient surgery centers across the United States.”
This story was updated with additional information from an Oct. 6 news release from Aurora Spine.