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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP110002
Supplement NumberS015
Date Received09/30/2016
Decision Date05/05/2017
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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