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
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Zimmer Biomet Spine, Inc.; 10225 Westmoor Drive; Westminster, CO 80021
• PMA Number: P110009
• Supplement Number: S035
• Date Received: 02/06/2023
• Decision Date: 08/01/2023
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for the addition of H4.5mm inserts to the Mobi-C® Cervical Disc Prosthesis System.