|
Device | VISTA LORDOTIC INTERBODY FUSION CAGE |
Generic Name | Intervertebral fusion device with bone graft, lumbar |
Regulation Number | 888.3080 |
Applicant | Zimmer Spine, Inc 7375 Bush Lake Road Minneapolis, MN 55439 |
PMA Number | P950002 |
Supplement Number | S013 |
Date Received | 12/24/2003 |
Decision Date | 01/29/2004 |
Reclassified Date
|
07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE VISTA LORDOTIC DEVICE TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VISTA LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO CONTINUOUS LEVELS FROM L4-L5 AND/OR L5-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). 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. VISTA LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH. |