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