This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the use of the lumbar i/f cage component of the lumbar i/f cage(r) with vsp(r) spine system with additional pedicle screw spinal systems. Specifically, for use with the following six additional posterior pedicle screw spinal systems: 1) the ti alloy version of the vsp spine system; 2) ti alloy and stainless steel versions of the isola spine system; 3) timx spine system; and 4) the ti alloy and stainless steel versions of the moss miami spine system. In addition, the device, as modified, will be marketed under the trade name lumbar i/f cage system. The indication for these implants has not been changed from that approved on february 2, 1999.
| Device | LUMBAR I/F CAGE WITH VSP SPINE SYSTEM |
| Classification Name | Spinal Pedicle Screw, Fixation, Appliance System |
| Generic Name | Spinal Pedicle Screw, Fixation, Appliance System |
| Applicant | DEPUY SPINE,INC |
| Date Received | 2000-04-06 |
| Decision Date | 2001-01-12 |
| PMA | P960025 |
| Supplement | S004 |
| Product Code | MCV |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY SPINE,INC 325 Paramont Drive raynham, MA 02767 |
| 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 |