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.
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.
| Device | BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Generic Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DEPUY SPINE,INC |
| Date Received | 1996-07-25 |
| Decision Date | 1999-02-02 |
| Notice Date | 1999-04-12 |
| PMA | P960025 |
| Supplement | S |
| Product Code | MAX |
| Docket Number | 99M-0894 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | DEPUY SPINE,INC 325 Paramont Drive raynham, MA 02767 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960025 | Original Filing | |
| S011 | 2003-08-04 | Normal 180 Day Track |
| S010 | 2003-02-24 | Normal 180 Day Track |
| S009 | 2001-12-26 | Real-time Process |
| S008 | 2001-09-04 | Normal 180 Day Track |
| S007 | 2001-05-17 | Normal 180 Day Track |
| S006 | 2001-03-27 | Normal 180 Day Track |
| S005 | 2000-06-06 | Normal 180 Day Track |
| S004 | 2000-04-06 | Real-time Process |
| S003 | 2000-03-23 | Real-time Process |
| S002 | 2000-03-06 | Normal 180 Day Track |
| S001 | 1999-06-07 | Normal 180 Day Track No User Fee |