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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.
 
DeviceSECURE-C CERVICAL ARTIFICIAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantGlobus Medical, Inc.
2560 General Armistead Ave.
Audubon, PA 19403
PMA NumberP100003
Supplement NumberS002
Date Received06/06/2013
Decision Date09/06/2013
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL DEVICE-SPECIFIC INSTRUMENTATION ASSOCIATED WITH THE SECURE®-C CERVICAL ARTIFICIAL DISC.
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