Osteotech Gets 510(k) Extension for Grafton
BY DAVID KRESSEL, NOVEMBER 15, 2005
The FDA said they are giving Osteotech (OSTE) an extension to its previously announced November 15th deadline to get 510(k) clearance for its Grafton DBM. In a letter dated September 16, 2005, the FDA required all DBM manufacturers to have cleared 510(k) applications covering their DBM products by November 15, 2005. However, the FDA has not had time to review OSTE's filing, and is permitting OSTE to continue selling Grafton until the FDA can make a decision.
The stock was up 6% on the news, presumably because with the deadline rapidly approaching and no positive announcement from OSTE, investors worried the application would be denied.
