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. |
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Device | 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 | S013 |
Date Received | 12/31/2015 |
Decision Date | 01/21/2016 |
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 |
Approval Order Statement FOUR MANUFACTURING CHANGES, WHICH INCLUDED REPLACEMENT OF A WIRE CUTTING MACHINE, ADDITION OF NEW POLISHING STATIONS, UPDATES TO LASER MARKING MACHINES, AND THE ADDITION OF UPDATED TENSILE TESTING MACHINES. |
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