Aurora Spine secures 510(k) clearance from the FDA for its TiNano implants for spinal fusion procedures.
Aurora Spine (TSX:ASG.V) said it won 510(k) clearance from the FDA for its TiNano coated interbody systems for spinal fusion procedures.
Carlsbad, Calif.-based Aurora said the implants are coated with a titanium plasma spraydesigned to encourage bpone ingrowth. The nod from the federal watchdog agency includes anterior cervical and transforaminal lumbar indications, according to a press release.
“This FDA clearance is a major achievement for Aurora Spine. These intervertebral implants are developed to support the entire spine from cervical to lumbar and to accommodate the company’s Zip minimally invasive interspinous fusion system portfolio as well as other fusion products on the market,” president & CEO Trent Northcutt said in prepared remarks.
Aurora is planning to use the proceeds from a $5 million stock offering toward the manufacturing, sales and marketing of its Zip spinal fusion line and other FDA-approved devices.
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Source: www.massdevice.com; Chris Walker; February 11, 2014.