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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 NumberS015
Date Received06/10/2024
Decision Date07/10/2024
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updated labeling to communicate storage temperature limitations on external packaging and instructions for use
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