Note: 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. |
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Device | LUMBAR I/F CAGE(R) SYSTEM |
Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
Applicant | DEPUY SPINE,INC 325 PARAMONT DRIVE RAYNHAM, MA 02767 |
PMA Number | P960025 |
Supplement Number | S008 |
Date Received | 09/04/2001 |
Decision Date | 03/01/2002 |
Reclassified Date
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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 A WEDGED VERSION OF THE I/F CAGE COMPONENT. THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999. |
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