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Xtant Medical announces FDA approval of DBM putty

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Xtant Medical Holdings Inc. recently announced its subsidiary, Bacterin International Inc., has received FDA 510(k) clearance of OsteoSelect PLUS Demineralized Bone Matrix Putty.

Comprised of OsteoSelect putty and demineralized cortical chips, the company touts OsteoSelect PLUS will eliminate the need to mix bone chips into demineralized bone matrix putty. In addition to saving procedural time, Xtant Medical believes OsteoSelect PLUS can reduce graft variability as well.

Xtant Medical plans to launch OsteoSelect PLUS in Q4 2015, according to a company release.

“We are very pleased with the FDA’s decision to approve OsteoSelect PLUS for marketing and distribution,” Gregory Juda, MD, Bacterin's chief scientific officer, stated in the release. “We developed this next generation bone graft material in response to surgeon demand using design input from surgeon customers. Because of their involvement in the development process, we are confident that OsteoSelect PLUS will be successfully received in the market and will serve to make our comprehensive product portfolio even stronger.”

Reference: www.microport.com.