Bioventus Bone Graft Strip Gains FDA 510(k) Clearance
Bioventus has received 510(k) clearance from the FDA for a strip version of its Signafuse bioactive bone graft.
The product is designed to support spinal fusion and the formation of new bone. It has been available in putty form since 2014. The strip format offers more flexibility for surgical procedures, such as correction of spinal deformity.
Bioventus said it plans to launch the product in the U.S. in the third quarter.