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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.
 
DeviceSimplify Cervical Artificial Disc
Generic NameProsthesis, intervertebral disc
ApplicantGlobus Medical, Inc.
2560 General Armistead Ave.
Audubon, PA 19403
PMA NumberP200022
Supplement NumberS010
Date Received09/28/2022
Decision Date03/15/2023
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the manufacturing site transfer for the Simplify® Cervical Artificial Disc.
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