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
CLIA
CTO Canada Registration
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FDA Biologics Registration
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FDA Hardware Registration
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Health Canada Device Registration — OsteoSelect DBM Putty
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Health Canada Device Registration — Silex
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ISO 13485
MDSAP
Compliance program
California State Tissue Bank License
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Delaware State Tissue Bank License
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Florida State Tissue Bank License
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Illinois State Tissue Bank License
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Louisiana State Tissue Bank License
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Maryland State Tissue Bank Permit
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New York State Tissue Bank License
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Oregon State Tissue Bank License
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Xtant MedicalHeadquartered in Montana and spun out of Montana State University’s Center for Biofilm Engineering, Xtant Medical develops and manufactures regenerative biologics, human tissue grafts, and spinal fixation systems for orthopedic and neurological surgery. The company operates Montana’s largest tissue bank and vertically integrates donor recovery, patented processing, and distribution, using technologies such as BacteRinse™ to preserve native growth factors. Its work is rooted in honoring tissue donors while helping surgeons support bone healing and spinal fusion.MIAMISBURG, OH
OrthofixFounded in 1980, Orthofix is a Lewisville, Texas-based medical technology company that develops devices and biologic solutions for spine care and limb reconstruction. Its work spans reconstructive and regenerative treatment, including bone-growth therapies and the 7D FLASH Navigation System, with products used to help patients regain mobility in more than 60 countries. Orthofix also develops biologics through its in-house tissue bank in Irvine, California, and collaborations with MTF Biologics.WAYNE, PA
Exsurco MedicalFrom its stand-alone medical-device manufacturing facility, Exsurco Medical engineers and makes precision devices for skin grafting, wound debridement, and tissue-bank recovery. The Wakeman company’s Amalgatome platform grew from tissue-bank tools into the Amalgatome SD, a surgical device for burn and trauma care, while its products have expanded into international tissue-bank markets. Exsurco opened its manufacturing facility and received ISO 13485 certification in 2015.WAKEMAN, OH
SpiTrex OrthopedicsSpiTrex Orthopedics grew from Mediliant, which began with a management buyout in 2014 and later expanded through partnerships and acquisitions in the United States and Europe. Today, it serves medical-device companies as a contract manufacturer focused on bringing orthopedic implants and instruments from concept through commercialization. Its global facilities are ISO 13485-certified and FDA registered.LANCASTER, PA