Aurora Spine Corporation achieves FDA 510(k) clearance for DEXA-C
The FDA has granted 510(k) clearance for the DEXA-C cervical interbody system from Aurora Spine Corporation, according to a company press release.
“This approval is the first of its kind in the world by offering an implant based upon a patient's bone density. It is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score, which indicates a patient's bone density,” Trent Northcutt, president and CEO of Aurora Spine, said in the release.
DEXA-C is a new line of cervical cages for anterior cervical discectomy with fusion procedures. The product is designed to improve spinal surgery outcomes by matching a patient’s bone density and DEXA T-score.