Osteotech receives second FDA marketing clearance for Grafton bone-defect paste

By Angela McDaniels

Seattle, Dec. 5 - Osteotech Inc. said that the U.S. Food and Drug Administration granted a second 510(k) marketing clearance for Grafton Plus DBM Paste for use in filling or augmenting bone defects in dental, oral and cranio/maxillofacial surgical procedures.

The company 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 in November, Osteotech said.

"We look forward to the FDA clearing, in the near future, the remaining three 510(k) applications covering our DBM family of products," said Sam Owusu-Akyaw, Osteotech president and chief operating officer, in a company news release.

Osteotech, headquartered in Eatontown, N.J., provides human bone and bone connective tissue for transplantation.

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