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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.
 
DeviceBAK/C VISTA CERVICAL INTERBODY FUSION DEVICE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSULZER SPINE-TECH
7375 BUSH LAKE RD.
MINNEAPOLIS, MN 55439
PMA NumberP980048
Supplement NumberS003
Date Received04/12/2004
Decision Date10/06/2004
Reclassified Date 07/12/2007
Product Code MAX 
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 BAK/C VISTA DEVICE, A MODIFICATION TO THE ALREADY APPROVED BAK/C DEVICE. THE BAK/C VISTA DIFFERS FROM THE BAK/C DEVICE IN THE FOLLOWING MANNERS: 1) THE BAK/C VISTA HAS TWO LARGE OFFSET SUPERIOR-INFERIOR (SI) HOLES FOR BONE INGROWTH WHEREAS THE BAK/C HAS MANY SMALL HOLES AT VARIOUS CIRCUMFERENTIAL AND LONGITUDINAL LOCATIONS, AND 2) THE BAK/C VISTA IS MADE OF PEEK OPTIMA LT1 AND THE BAK/C IS MADE OF TITANIUM (TI-6A1-4V). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAK/C VISTA AND IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE DDD) OF THE CERVICAL SPINE WITH ACCOMPANYING RADICULAR SYMPTOMS AT ONE DISC LEVEL. DDD IS DEFINED AS DISCOGENIC PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. BAK/C IMPLANTS ARE USED TO FACILITATE FUSION IN THE CERVICAL SPINE AND ARE PLACED VIA AN ANTERIOR APPROACH AT THE C-3 TO C-7 DISC LEVELS USING AUTOGRAFT BONE.
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