| 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 | SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE |
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| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
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| Applicant | Depuy Spine, Inc.
325 Paramont Dr.
Raynham, MA 02767 |
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| PMA Number | P960025 |
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| Supplement Number | S011 |
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| Date Received | 08/04/2003 |
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| Decision Date | 03/05/2004 |
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| Reclassified Date | 07/12/2007 |
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| Product Code |
MCV |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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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