Aurora Spine Corporation Announces FDA 510(k) Clearance for its SiLO TFX™ MIS Sacroiliac Joint Fixation System – QNT Press Release


CARLSBAD, Calif., Oct. 06, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB:ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the patented minimally invasive SiLO TFX MIS Sacroiliac Joint Fixation System. The Aurora Spine SiLO TFX MIS Sacroiliac Joint Fixation System, is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The SiLO TFX MIS Sacroiliac Joint Fixation System includes a Transfixing-Cone, an ilium screw, a sacrum screw and associated instrumentation. The SiLO TFX implants are designed 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 Chief Executive Officer. “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.”

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Full story available on Benzinga.com



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