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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® P&F Cervical Disc Prosthesis
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP110009
Supplement NumberS038
Date Received03/09/2026
Decision Date03/23/2026
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 (IKH) for titanium powder used in the plasma spray coating of Mobi-C® inferior and superior endplates, and qualification of a back-up final cleaning line (HAMO 210 #LA2165) for cleaning of Mobi-C® inserts and jaws performed at the same Viant facility
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