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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 indications)
Generic NameProsthesis, intervertebral disc
ApplicantZimmer Biomet Spine, Inc.
10225 Westmoor Drive
Westminster, CO 80021
PMA NumberP110002
Supplement NumberS022
Date Received09/04/2019
Decision Date11/13/2019
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
Approval Order Statement  
Approval for a new manufacturing site to be used for kitting and shipping of Mobi-C as well as reconditioning and servicing of instruments from the field for reuse.
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