United States (English)
German (Deutsch)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
North Carolina
1800 A. North Greene Street
Greenville, North Carolina 27834
American Association of Tissue Banks (AATB)
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. - (North Carolina)
International Organization of Standards (ISO)
- ISO 13485: 2016 - Tutogen Medical, GmbH (Germany)
- ISO 13485: 2016 - RTI Surgical (Florida)
- ISO 13485:2016 - FKA Pioneer Surgical Technology (Greenville)
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 - FKA Pioneer Surgical Technology (Greenville)
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
CE Certificates
- CE 52820 - FKA Pioneer Surgical Technology (Greenville)