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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 Two-level
Generic NameProsthesis, intervertebral disc
ApplicantZimmer Biomet Spine, Inc.
10225 Westmoor Drive
Westminster, CO 80021
PMA NumberP110009
Supplement NumberS029
Date Received01/19/2021
Decision Date02/17/2021
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Qualify an existing manufacturing site as an alternate supplier to perform the titanium (Ti) and hydroxyapatite (HA) coating operations for the Mobi-C® implant endplates.
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