FDA CLEARS COLLAGEN MATRIX'S BONE GRAFT MATERIAL
Collagen Matrix has received FDA 510(k) clearance of its natural anorganic bone graft material intended for use in oral surgical applications involving bone repair.
The natural anorganic bone graft material is derived from bovine cancellous and cortical bone. The organic components of the bone are removed in a process that leaves the natural mineral component for use as an osteoconductive material in bone repair applications. Due to its natural structure, the anorganic bone mineral is physically and chemically comparable to the mineralized matrix of human bone.
The products cleared include the anorganic bone mineral alone, anorganic bone mineral with collagen, and anorganic bone mineral with collagen in the block form. The addition of Type I collagen to the anorganic bone mineral extends the product offering to a mineral-collagen composite bone graft material intended to enhance the handleability of the product.