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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPARED FUSION DEVICE
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 pyramid place
memphis, TN 38132
PMA NumberP000058
Supplement NumberS015
Date Received11/15/2004
Decision Date02/04/2005
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS. SPECIFICALLY, THESE DESIGN CHANGES INVOLVED THE INCORPORATION OF A ROUNDED PROFILE TO THE CLOSED END OF THE TAPERED CAGE COMPONENTS. THE MODIFIED TAPERED CAGE COMPONENTS CAN ONLY BE IMPLANTED VIA AN ANTERIOR OPEN SURGICAL APPROACH.
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