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: MOBI-C CERVICAL DISC PROSTHESIS
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Highridge Medical, LLC; 10225 Westmoor Dr.; Westminister, CO 80021
• PMA Number: P110002
• Supplement Number: S001
• Date Received: 09/12/2013
• Decision Date: 05/27/2014
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.