Because safety is so important, all Bacterin products are distributed sterile in the final package via low-dose gamma irradiation. We utilize BacteRinse® Sterile Technology to process our allografts while maintaining allograft integrity. Every lot of OsteoSelect® DBM Putty is tested for osteoinductivity after gamma irradiation in an animal model. This is a testament of our commitment to the safety of the product as well as our demineralization technology. We are not required to test every lot; however we feel it is of the utmost importance to have consistency in the quality and clinical efficacy of our products.
Bacterin’s Quality Management System (QMS) complies with all applicable regulatory requirements. We are registered with the FDA, accredited by the AATB, ISO 13485 certified, CLIA certified ,and have licensures for California, Florida, Louisiana, Maryland, Illinois, Delaware, and New York.