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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 Drive
Sunnyvale, CA 94085
PMA NumberP170036
Supplement NumberS001
Date Received03/07/2019
Decision Date08/02/2019
Product Code MJO 
Advisory Committee Orthopedic
Clinical TrialsNCT01609374
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the protocol for the Post-Approval Study (PAS) protocol.
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