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news.Orthofix International, a medical device company, has received 510(k) approval from the FDA for its next generation Firebird spinal fixation system.
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Firebird is a comprehensive system with a modular screw designed to provide surgeons with intra-operative flexibility during various thoracolumbar spine procedures, including the treatment of degenerative disc disease and deformity corrections.
The Firebird system can also be used during a minimally invasive surgical approach in conjunction with instrumentation available in the company’s ProView minimal access portal system. The company expects to make the Firebird system widely available in the US beginning during the first quarter of 2009.
Alan Milinazzo, president and CEO of Orthofix, said: “The Firebird system is an important addition to our expanding spine product portfolio, giving us new capabilities to assist surgeons in the treatment of deformity corrections.”