Sunday, February 16, 2014

FDA CLEARS AURORA SPINE’S TiNano

Auora Spine, Inc., which calls itself “an early stage company focused on bringing new solutions to the spinal implant market,” has received 510(k) clearance from the FDA for its sterile-packed coated fusion implants. Called TiNano, the devices are titanium plasma spray coated. The coating is used on PEEK Interbody implants. The company claims this coating allows for bone ingrowth due to its porous structure.

“Patient safety is the most important goal for Aurora Spine and that is the reason for every TiNano coated interbody implant being sterile packed,” said Laszlo Garamszegi, chief technology officer of the company.
The FDA clearance includes several of the firm’s interbody fusion devices, including configurations for Anterior Cervical (ACIF), Anterior Lumbar (ALIF), Posterior Lumbar (PLIF), Transforaminal Lumbar (TLIF) and Direct Lateral (DLIF) interbody spacers.
“This FDA clearance is a major achievement for Aurora Spine,” said Trent J. Northcutt, president and chief executive officer of the company. “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.”

No comments:

Post a Comment