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 (ONE-LEVEL INDICATION) |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
PMA Number | P110002 |
Supplement Number | S015 |
Date Received | 09/30/2016 |
Decision Date | 05/05/2017 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for manufacturing sites located at: 1) SAS Etablissements Maurice, MARLE, Zi Rue Lavoisier, Bp 46, Nogent France; 2)Marle Finishing SAS, 22 Rue de IaMollanche Sorbiers, Loire 42290, France; and 3) Marie Sferic SAS, Zone Artisanale, Rue du Courtois Prolongee 41500 MENARS France, for polishing endplates and machining the mobile insert of the device. |
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