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. 

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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.

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Presenters: Joe Ganley, athenahealthJeffrey Flynn, CASC, Gramercy Surgery CenterBryan Tsao, Access Center, Loma Linda University HealthJason Zepeda, Northridge Hospital Medical Center, CommonSpirit HealthGreg DeConciliis, PA-C, CASC, Boston Out­Patient Surgical Suites

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