Kuros Biosciences submitted an FDA 510(k) clearance regulatory package for its Fibrin-PTH (KUR-113).
Here are four things to know:
1. The KUR-113 device is intended for use with lumbar intervertebral body fusion devices.
2. The device comprises a natural fibrin-based healing matrix with an immobilized targeted bone growthfactor. It is designed to directly apply onto and around an intervertebral body fusion device as a gel.
3. KUR-133 will be combined with an interbody spacer device in the upcoming clinical trial for Kuros Biosciences' interbody spinal fusion product.
4. Kuros Biosciences plans to feature the spinal fusion product at the North American Association of Spinal Surgeons' orthobiologics course in Chicago, Oct. 19.