www.fdanews.com/articles/188546-synergy-biomedicals-bone-graft-product-cleared-by-fda
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Synergy Biomedical’s Bone Graft Product Cleared by FDA
September 25, 2018
The FDA granted 510(k) clearance for Synergy Biomedical’s Biosphere Flex, a strip-format bone graft product designed for optimized absorption of bone marrow aspirate.
The product can be used for a variety of surgical techniques and is composed of material that enables accurate control of bone healing.
When coated in bone marrow aspirate, the product becomes flexible and implantable in irregular bone surfaces, aiding in graft placement and optimizing healing potential.