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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 NameBRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameinterbody fusion device used with posterior pedicle screw fixation
Regulation Number888.3080
ApplicantDEPUY SPINE,INC
PMA NumberP960025
Date Received07/25/1996
Decision Date02/02/1999
Reclassified Date 07/12/2007
Product Code
MAX[ Registered Establishments with MAX ]
Docket Number 99M-0894
Notice Date 04/12/1999
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the lumbar i/f cage(r) with vsp(r) spine system. The device is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (ddd) at one or two spinal levels from l2-s1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360 degrees fusion) and posterior pedicle screw fixation. These pateints may have had a previous non-fusion spinal surgery at the involved spinal level(s). Ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 
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