NovaLign(TM) Orthopaedics, Inc. Announces its First 510(K) Clearance From the FDA for New Intramedullary Fixation System
“Attainment of this key milestone enables the company to move forward with its plans to commercialize new products that provide innovative treatment options for long bone fracture repair,” said
Extensive preclinical testing in accordance with internationally recognized testing standards and applicable FDA guidances support NovaLign’s 510(k) clearance. The company plans to initiate clinical studies in
Using current surgical approaches, trauma surgeons insert rigid intramedullary nails through the nearest joint. “The NovaLign(TM) extra-capsular intramedullary device allows a surgeon to repair a long bone fracture without violating the nearby joint space,” said
About NovaLign(TM) Orthopaedics Inc.:
NovaLign(TM) (http://www.novalign.com), formerly known as OsteoLign, Inc., is an early-stage start-up company founded in 2005 within The Innovation Factory, a
SOURCE NovaLign(TM) Orthopaedics, Inc.