SpineGuard seeks 510(k) clearance to expand use of spine surgery device

SpineGuard has filed for 510(k) FDA clearance to commercialize its Threaded PediGuard device for a new spinal application, the medical device company said Jan. 31. 

Advertisement

The company’s device is designed for accurate pedicle screw placement, but authorization from the FDA will allow the company to also commercialize its product for anterior approach instrumented spine surgery.

The filing represents SpineGuard’s first expanded application for its Threaded PediGuard outside of pedicle screw placement, Stéphane Bette, cofounder and deputy CEO of SpineGuard, said.

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.