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Device | BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS |
Generic Name | Intervertebral fusion device with bone graft, lumbar |
Regulation Number | 888.3080 |
Applicant | DEPUY SPINE,INC 325 PARAMONT DRIVE RAYNHAM, MA 02767 |
PMA Number | P960025 |
Date Received | 07/25/1996 |
Decision Date | 02/02/1999 |
Reclassified Date
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07/12/2007 |
Product Code |
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
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
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