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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000058
Date Received12/22/2000
Decision Date07/02/2002
Product Code NEK 
Docket Number 02M-0310
Notice Date 07/11/2002
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE. THIS DEVICE IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. INFUSE BONE GRAFT/LT-CAGE DEVICES ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN OR AN ANTERIOR LAPAROSCOPIC APPROACH. PATIENTS RECEIVING THE INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/LT-CAGE DEVICE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S042 S043 S044 S045 S046 S047 S014 S015 S016 S017 S005 
S006 S001 S025 S019 S020 S032 S033 S031 S040 S041 S004 S037 
S038 S023 S061 S063 S048 S054 S056 S051 S052 S050 S049 S057 
S058 S059 S053 S002 S003 S007 S008 S009 S010 S028 S029 S034 
S039 S036 S021 S022 S026 S027 S065 S060 S064 S062 S030 S068 
S067 S076 S077 S078 S079 S070 S071 S088 S069 S072 S083 S074 
S075 S073 S080 S081 S082 S086 S084 S087 S085 S089 S090 S091 
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