FDAnews Device Daily Bulletin

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

Dec. 6, 2005
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Osteotech recently announced that the Food and Drug Administration ("FDA") has cleared an additional 510(k) for Grafton Plus DBM Paste for use in dental, oral and cranio/maxillofacial procedures. In these procedures, Grafton Plus DBM Paste is intended to be used to fill and/or augment bone defects that may be surgically created or created by traumatic injury to the bone. On November 29, 2005, the Company announced that it had received 510(k) clearance for Grafton Plus DBM Paste for use as a bone graft extender, bone graft substitute and bone void filler in orthopedic procedures.

PR Newswire (http://www.prnewswire.com/news/index_mail.shtml?ACCT=104&STORY=/www/story/12-05-2005/0004227527&EDATE=)