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)

203KB

pdf California Tissue Bank License (.pdf)

820KB

pdf Delaware Tissue Bank License (.pdf)

61KB

pdf ISO 13485-216 BSI Certificate (.pdf)

873KB

pdf Maryland Tissue Bank Permit - Eatontown (.pdf)

389KB

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

457KB

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

95KB

pdf Oregon Tissue Bank License - Eatontown (.pdf)

407KB

pdf Canada CTO Registration Certificate (.pdf)

288KB

pdf FDA CBER HCTP Registration - Eatontown (.pdf)

14KB

SGT Tissue Licenses and Registration

pdf California (.pdf)

853KB

61KB

759KB

512KB

29KB

223KB

96KB

1.7MB

pdf SpinalGraft Technologies, LLC AATB Accreditation (.pdf)

137KB

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

14KB

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

Follow instructions below to download a copy

RTI: www.rtix.com/en_us/about/company-credentials

CTS: www.communitytissue.org/healthcare-professionals/licensure-and-accreditation/

AATB Website: www.aatb.org/accreditation/accredited-bank-search

In “bank search” field: type vendor name
Select vendor profile: accreditation number & expiration date provided
There also is “US map search”
Select region from map
Select certification vendor from list
Select “show pdf version” to download a copy this will provide: Accreditation number, expiration date, approvals

*If you require further information please contact, AATB@aatb.org or by phone: 703-229-1020

Other Resources

pdf Biologics Catalog (.pdf)