Born from Montana State University’s Center for Biofilm Engineering, Xtant Medical is a Montana-headquartered tissue bank and medical-device manufacturer developing orthobiologics and spinal fixation systems. Its vertically integrated operations span donor recovery, patented tissue processing and distribution, with technologies such as BacteRinse™ used to preserve growth factors while honoring each donation. Xtant says it has 25 years of clinical success and maintains AATB accreditation alongside ISO 13485 and MDSAP certification.
AATB Accreditation — Bacterin Biologics
certification
CLIA
certification
CTO Canada Registration
registration
FDA Biologics Registration
registration
FDA Hardware Registration
registration
Health Canada Device Registration — OsteoSelect DBM Putty
registration
Health Canada Device Registration — Silex
registration
ISO 13485
certification
MDSAP
compliance_program
California State Tissue Bank License
registration
Delaware State Tissue Bank License
registration
Florida State Tissue Bank License
registration
Illinois State Tissue Bank License
registration
Louisiana State Tissue Bank License
registration
Maryland State Tissue Bank Permit
registration
New York State Tissue Bank License
registration
Oregon State Tissue Bank License
registration