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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceLUMBAR I/F CAGE WITH VSP SPINE SYSTEM
Generic NameSPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
ApplicantDepuy Spine, Inc.
325 Paramont Dr.
Raynham, MA 02767
PMA NumberP960025
Supplement NumberS004
Date Received04/06/2000
Decision Date01/12/2001
Reclassified Date07/12/2007
Product Code MCV 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
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.
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