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)

465KB

pdf California Tissue Bank License (.pdf)

215KB

pdf Delaware Tissue Bank License (.pdf)

45KB

pdf ISO 13485-2003 Certificate (.pdf)

pdf Maryland Tissue Bank Permit - Eatontown (.pdf)

374KB

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

24KB

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

232KB

pdf Canada CTO Registration Certificate (.pdf)

2.8MB

pdf FDA CBER HCTP Registration - Eatontown (.pdf)

14KB

SGT Tissue Licenses and Registration

pdf California (.pdf)

204KB

45KB

666KB

300KB

40KB

222KB

326KB

580KB

pdf SpinalGraft Technologies, LLC AATB Accreditation (.pdf)

248KB

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

pdf Community Tissue Services AATB Accreditation (.pdf)

383KB

Other Resources

pdf Biologics Catalog (.pdf)

2.2MB

pdf Tissue FAQs (.pdf)

214KB