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
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)
International Organization of Standards (ISO)
- ISO 13485: 2016 - Tutogen Medical, GmbH (Germany)
- ISO 13485: 2016 - RTI Surgical (Florida)
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)
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.