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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.
 
DeviceM6-C Artificial Cervical Disc
Generic NameProsthesis, intervertebral disc
ApplicantSpinal Kinetics, LLC
501 Mercury Dr.
Sunnyvale, CA 94085
PMA NumberP170036
Supplement NumberS008
Date Received12/22/2020
Decision Date08/06/2021
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Infinity Labs SD located at 1836 Stone Avenue, San Jose, California, 95125, for ethylene oxide sterilization of the M6-C Artificial Cervical Disc system.
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