Bio2 Technologies, Inc. Announces Receipt of FDA 510(k) Clearance for CLM Bioactive Scaffold

by PRNewswire

WOBURN, Mass., Dec. 19, 2014 /PRNewswire/ -- Bio2 Technologies, Inc. (a privately held development stage company) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its CLM Bioactive Scaffold. CLM is constructed from bioactive glass, a resorbable implantable material with a well-studied mechanism of action and a long track record of safe clinical use.  Following four years of research and pre-clinical testing Bio2 has successfully applied its proprietary CLM process technology to produce a rigid, osteoconductive material with an interconnected porous structure facilitating the ingrowth and remodeling of healthy bone.

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