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: LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Highridge Medical, LLC; 10225 Westmoor Dr.; Westminister, CO 80021
• PMA Number: P110002
• Supplement Number: S021
• Date Received: 04/17/2018
• Decision Date: 05/15/2018
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Update the cutting fluid and bactericidal agent for the machines used to manufacture Mobi-C components.