FDAnews Device Daily Bulletin

OSTEOTECH RECEIVES ITS FIRST GRAFTON DBM 510(K) FDA CLEARANCE

Nov. 30, 2005
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Osteotech recently announced the Food and Drug Administration ("FDA") has cleared its 510(k) for Grafton Plus DBM Paste for use as a bone graft extender, bone graft substitute and bone void filler in orthopedic procedures. Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer, stated, "The Grafton Plus DBM Paste 510(k) for orthopedic use is the first of five previously reported 510(k) applications that the Company has filed with the FDA covering its family of Grafton DBM products. We are particularly pleased that this 510(k) application has been cleared for all the ndications for which we applied. To our knowledge, this is the only DBM product on the market to receive clearance as a bone graft extender, bone graft substitute and bone void filler."
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