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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.
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
325 paramont drive
raynham, MA 02767
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011