Duratech™ BioRegeneration Matrix is a medical device that has been devekioed by Osteotech, Inc (Nasdaq:OSTE). Now the company wants to bring this product into the market. However, it needs the approval from the United States of America’s toughest regulator – the Food and Drug Administration (FDA). For this reason, Osteotech submitted a 510(K) application to the FDA on December 17, 2009.It usually takes the FDA about 90 days to review a 510(K) submission, so the company expects to get response from the FDA on March 17, 2010. However, the FDA may not announce its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.

According to the company, the Duratech™ BioRegeneration Matrix, which has been developed using Osteotech’s