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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 NumberS008
Date Received01/14/2022
Decision Date02/09/2022
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the location of a mid-process inspection of device components due to acquisition and transfer of ownership.
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