Aurora Spine receives FDA 510(k) clearance for anterior cervical plate system
Aurora Spine Corporation has announced FDA 510(k) clearance for the Apollo anterior cervical plate system, according to a press release.
This anterior cervical plate system (ACP) system is designed to reduce postoperative complications after spinal surgery such as dysphagia, malalignment and ossification, according to the release.
“There are an estimated 180,000 cervical fusion procedures performed in the United States each year to relieve compression on the spinal cord or nerve roots. Receiving FDA 510(k) clearance for the Apollo ACP system reflects Aurora Spine’s commitment to deliver innovative, modern technology for the anterior cervical spine and to support positive clinical outcomes,” Trent Northcutt, president and CEO of Aurora Spine, said in the release. “The launch of Apollo ACP is key to our long-term cervical implant strategy and represents a significant opportunity for growth, as cervical spine procedures comprise an approximately $2.6 billion segment of the global spine market.”
“This approval is an important piece to the puzzle for advancing Aurora Spine’s key initiative of bringing more proprietary-based products to the marketplace and decreasing our reliance on third-party products,” Northcutt said.
He added, “This approval is a great step for Aurora in fiscal 2021 and we are hopeful to deliver several new key products throughout the year.”
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