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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.
 
DeviceSABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE
Generic NameSPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
ApplicantDEPUY SPINE,INC
325 PARAMONT DRIVE
RAYNHAM, MA 02767
PMA NumberP960025
Supplement NumberS011
Date Received08/04/2003
Decision Date03/05/2004
Reclassified Date 07/12/2007
Product Code MCV 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SABER LUMBER I/F CAGE. IN ADDITION, THIS SUPPLEMENT REQUESTED THE APPROVAL OF TWO NEW SIZES, WHICH WILL NOW BE MARKETED AS THE JAGUAR LUMBAR I/F CAGE. THESE DEVICES ARE 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 PATIENTS MAY HAVE HAD PREVIOUS NON-FUSION SPINAL SURGERY AT THE INVOLVED SPINAL LEVELS(S). DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.
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