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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP000058
Date Received12/22/2000
Decision Date07/02/2002
Product Code
NEK[ Registered Establishments with NEK ]
Docket Number 02M-0310
Notice Date 07/11/2002
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S014 S015 S016 S017 S019 S020 S021 S022 
S023 S025 S026 S027 S028 S029 S030 S031 S032 
S033 S034 S036 S038 S039 S040 S041 S042 S043 
S044 S045 S046 S047 S048 S049 S050 S051 S052 
S053 S054 
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