|
Device | LUMBAR I/F CAGE WITH VSP SPINE SYSTEM |
Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
Applicant | DEPUY SPINE,INC 325 PARAMONT DRIVE RAYNHAM, MA 02767 |
PMA Number | P960025 |
Supplement Number | S005 |
Date Received | 06/06/2000 |
Decision Date | 09/08/2000 |
Reclassified Date
|
07/12/2007 |
Product Code |
MCV |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE MATERIAL OF THE I/F CAGE DEVICE COMPONENT FROM INJECTION MOLDED PEKEKK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70 TO INJECTION MOLDED PEEK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70. |