Astura Medical Receives FDA 510(k) Clearance For BRIDALVEIL OCT Stabilization System
Astura Medical, a high growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System.
“The FDA 510(k) clearance of our BRIDALVEIL OCT System, demonstrates the power of our innovation engine at Astura Medical and represents our best system released to date. We are excited for the opportunity to provide our rapidly expanding group of surgeon partners the most complete OCT technology offering on the market today, to further enhance their ability to provide the best in patient care,” said Thomas Purcell, Vice President.
Designed with the most complex and demanding cases in mind, BRIDALVEIL OCT provides a comprehensive offering of screw options (single-lead, dual-lead, high-top, and smooth shank) ranging from 3.5mm to 5.5mm in diameter that are compatible with either a 3.5mm or 4.0mm rod in titanium or cobalt chrome. The system also provides an extensive line of connectors, transition rods, and instrumentation options to allow surgeons the ability to seamlessly transition across multiple segments of the spine.
The launch of BRIDALVEIL OCT represents the 11th system launched since the company was founded in 2014. The company anticipates high demand for BRIDALVEIL OCT in addition to the robust growth seen in its current line of products.
Astura Medical will be showcasing BRIDALVEIL OCT, along with the Company’s other systems at Exhibit 565 during the 32nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27th.