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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 NumberS011
Date Received06/09/2022
Decision Date07/01/2022
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  
Additional weld system EQ 0169 Amada Miyachi Laser System to increase manufacturing capacity.
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