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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 for use at One Level
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP110002
Supplement NumberS040
Date Received08/27/2026
Decision Date09/16/2026
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of a new raw material supplier (CAM Bioceramics) for hydroxyapatite powder used in the coating of Mobi-C® inferior and superior endplates, and qualification of a new sealing equipment (CeraTek) for sealing of the final packaging pouch of Mobi-C® devices at the same Viant facility
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