Premarket Approval (PMA)

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.

• Device: M6-C Artificial Cervical Disc
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Spinal Kinetics, LLC; 501 Mercury Dr.; Sunnyvale, CA 94085
• PMA Number: P170036
• Supplement Number: S006
• Date Received: 09/11/2020
• Decision Date: 10/08/2020
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.