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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NameINFUSE/MASTERGRAFT CERAMIC OR INFUSE HDE KIT
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis, TN 38132
HDE NumberH040004
Date Received06/28/2004
Decision Date10/10/2008
Product Code
OJZ
Docket Number 08M0562
Advisory Committee Orthopedic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for the infuse/mastergrafttm posterolateral revision device. This device is indicated for the repair of symptomatic, posterolateral lumbar spine pseudarthrosis. This device is intended to address a small subset of patients for whom autologous bone and/or bone marrow harvest are not feasible or are not expected to promote fusion. These patients are diabetics and smokers. This device is indicated to treat two or more levels of the lumbar spine.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
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