| 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 | BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE |
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| Generic Name | Intervertebral fusion device with bone graft, lumbar |
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| Regulation Number | 888.3080 |
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| Applicant | Zimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, MN 55439 |
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| PMA Number | P950002 |
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| Supplement Number | S007 |
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| Date Received | 02/11/1999 |
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| Decision Date | 05/01/2002 |
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Reclassified Date
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07/12/2007 |
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| Product Code |
MAX |
| 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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Approval Order Statement
APPROVAL TO ADD THE BP/LORDOTIC TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BP/LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L4-L5 AND/OR L5-S1 LEVELS. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). BP/LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR LAPAROSCOPIC APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT. |
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