CancellOss™ Mineralized Cancellous Bone Matrix Allograft
CancellOss™ Mineralized Cancellous Bone Matrix Allograft
*100% Mineralized Cancellous Bone Powder
*Particle Size: .500 – 1.00mm or .850 – 1.00mm (0.5cc only, available in Jars)
*Available in 0.5cc, 1.0cc, 2.0cc and 5.0cc vials
*Human Allograft Material provides osteoconductive and osteoinductive matrix
*Stimulates bone formation while providing a scaffold for new bone growth
*Tissue processing in accordance with AATB standards and FDA regulations
Product Description:
This product contains Human Allograft Material (referred to as “Graft”) collected from human cadaveric donors.
Alltissue processed for Impladent Ltd. is recovered by U.S. tissue banksas well as a completed donor chart for the enclosed product includingbut not limited to: serology results, preprocessing culture results,medical and social history evaluation and serodilution calculations thatare conducted by or contract tested for the tissue bank. It has beenreviewed and approved for transplantation by the tissue bank’s MedicalDirector.
Donorscreening and testing is performed in accordance with the AmericanAssociation of Tissue Banks (AATB) standards and U.S. Food and DrugAdministration (FDA) regulations. All processing documentation has beenreviewed and approved by the tissue bank’s Quality Assurance department;each lot of product is manufactured using tissue from a single donor.There is no pooling of donor tissue.
Adonor serum sample is tested by a CLIA Certified Lab using FDA licensedscreening tests and found to be negative or non-reactive for antibodiesto human immunodeficiency virus type 1 and type 2 (anti-HIV 1 andanti-HIV 2), hepatitis B surface antigen (HbsAg), hepatitis B coreantibody (HbcAb), antibodies to the hepatitis C virus (anti-HCV), andthe human T-lymphotrophic virus type I antibody (anti-HTLV I). The serumtests negative for syphilis using a FDA licensed confirmatory test. Thedonor also tests negative for HIV using Polymerase Chain Reaction (PCR)technology or an FDA-licensed NAT test.
