Bacterin's OsteoSelect PLUS Demineralized Bone Matrix Putty has received 510(k) clearance from the FDA. The product, which includes demineralized cortical chips and OsteoSelect Putty, is set for launch in the fourth quarter.
The FDA has granted 510(k) clearance for CryoLife's PerClot Topical, a hemostatic powder made of polysaccharide granules used as topical dressing to temporarily stop mild bleeding of surgical wounds, cuts, lacerations and nosebleeds. Commercialization of the product is expected to begin in June.
Abyrx has entered into a distribution deal with SurgiCor to help bring its hemostatic bone putty products to orthopedic and spinal surgeons across the U.S. The deal covers Abyrx's Hemasorb, Hemasorb Plus, Hemasorb Apply and AHBP.
The FDA has granted CryoLife conditional investigational device exemption approval for its PerClot system. The company said the device, which consists of absorbable polysaccharide granules, is designed for use as an ancillary hemostatic tool when conventional methods to control bleeding during surgery are impractical or ineffective.