ALLOGRAFT TISSUE RESOURCE CENTER FOR HEALTHCARE PROFESSIONALS

Overview

Medtronic Allograft Tissue covers surgical procedures in spinal, orthopedic, sports medicine, and dental applications — literally from head to toe. Our bone graft options span osteoinduction, cell promotion, and cell enhancements to cell delivery, resulting in fusion success. We offer a wide variety of shapes, sizes, and delivery methods — all to meet your surgical needs. Below are some Allograft Tissue resources you may need to download.

Medtronic Eatontown Facility Quality Certifications

pdf AATB Accreditation (.pdf)

pdf California Tissue Bank License (.pdf)

pdf Delaware Tissue Bank License (.pdf)

pdf ISO 13485-216 BSI Certificate (.pdf)

873KB

pdf Maryland Tissue Bank Permit - Eatontown (.pdf)

pdf New Jersey Drug and Medical Device Registration (.pdf)

pdf New York Tissue Bank License - Eatontown (.pdf)

100KB

pdf Canada CTO Registration Certificate (.pdf)

159KB

pdf FDA CBER HCTP Registration - Eatontown (.pdf)

14KB

SGT Tissue Licenses and Registration

pdf California (.pdf)

860KB

100KB

pdf SpinalGraft Technologies, LLC AATB Accreditation (.pdf)

pdf FDA CBER HCTP Registration Spinal Graft Technologies (.pdf)

24KB

FDA Documents - 510(k) Letters

K043048 GRAFTON Plus™ DBM Paste510k for Spine-Ortho
K042707 GRAFTON Plus™ DBM Paste 510k for Cranio-Maxillofacial
K051195 GRAFTON™ DBM (Gel, Flex, Matrix, Putty, Crunch, Orthoblend) 510k for Spine-Ortho
K051188 GRAFTON™ DBM (Gel, Flex, Matrix, Putty, Crunch) 510k for Cranio-Maxillofacial
K082615 GRAFTON™ II eDBM 510k

Follow these instructions to download a copy:
- Under “device” name -enter “Grafton"
- Select appropriate 510(k) number from list above
- Select “summary” to download a copy

Download 510(K) Letter

Community tissue Services & rti

pdf Community Tissue Services & RTI (.pdf)

Other Resources

pdf Biologics Catalog (.pdf)

2.0MB

pdf Tissue FAQs (.pdf)

214KB