Aurora Spine's Dexa Solo-L fusion device gets FDA nod
seekingalpha2022-06-07 02:47
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Aurora Spine (OTCQB:ASAPF) said the U.S. Food and Drug Administration granted 510(k) clearance to its Dexa Solo-L spinal fusion system.
The company said in a June 6 press release that the system, which is part of the DEXA Technology platform, is a standalone device for anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures and is the first of its kind device for lumbar spine in the world.
The system is also the first color-coded, bone-mimicking structure implant in the marketplace, according to the company.
"We are thrilled to receive this new approval for our DEXA SOLO-L device, the world’s first patented and FDA-cleared, color-coded ALIF standalone device," said President and CEO Trent Northcutt.
source:seekingalpha
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