About Innovation Roadmap Operational Excellence RTI Donor Services Careers News HOME ABOUT COMPANY CREDENTIALS Company Credentials The following facilities are licensed for manufacturing, processing, storing and distribution. For a full list of our locations, please visit our contact us page. Florida 11621 Research Circle Alachua, Florida 32615 13709 Progress Boulevard Alachua, Florida 32615 Germany Industriestrasse 6 Neunkirchen am Brand, Germany D-91077 Michigan 375 River Park Circle Marquette, Michigan 49855 North Carolina 1800 A. North Greene Street Greenville, North Carolina 27834 American Association of Tissue Banks (AATB) AATB Accreditation Certificate - (Florida) FDA Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) FDA establishment registrations for 361 HCT/Ps and medical devices are submitted annually and valid for the annual registration year (HCT/P) or until expiration date (devices) as listed. RTI Surgical, Inc. - (Florida) Tutogen Medical, GmbH - (Germany) FDA Establishment Registration for Medical Devices RTI Surgical, Inc. - (Florida) Tutogen Medical, GmbH - (Germany) RTI Surgical, Inc. - (Michigan) RTI Surgical, Inc. - (North Carolina) International Organization of Standards (ISO) ISO 13485: 2016 - Tutogen Medical, GmbH (Germany) ISO 13485: 2016 - RTI Surgical (Florida) ISO 13485: 2016 - Pioneer Surgical Technology (all locations) International Facility Registrations Canada - CTO Registration Certificate - Tissue - RTI Surgical (Florida) Canada - Registration Certificate - Medical Device - RTI Surgical (Florida) Medical Device Single Audit Program (MDSAP) MDSAP 704608 - RTI Surgical (Florida) MDSAP 700908 - Pioneer Surgical Technology (all locations) CE Certificates CE 52820 Certificate - Pioneer Surgical Technology (Michigan) State Tissue Banking Licenses State of California Tissue Bank License - RTI Surgical (Florida) State of Florida Tissue Bank License - RTI Surgical (Florida) State of Florida Tissue Bank License - RTI Surgical (Florida, South Wing) State of Maryland Tissue Bank License - RTI Surgical (Florida) State of New York Tissue Bank License - RTI Surgical (Florida) State of Oregon Registration Letter - RTI Surgical (Florida) State of Illinois Registration Letter - RTI Surgical (Florida) State of Delaware Tissue Bank Registration - RTI Surgical (Florida) * These are the only states that require licensure for processing and distributing human tissue. Biomedical Laboratory Certifications and Permits Centers for Medicare & Medicaid Services CLIA Certificate of Compliance - (Florida) About History of Innovation Mission & Values Leadership Corporate Compliance Corporate Social Responsibility Company Credentials Labeling Contact Us © 2021 RTI Surgical, All rights reserved Terms Of Use • Web Privacy Policy and Transparency Disclosure Notice