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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.
 
DeviceLDR Spine Mobi-C Cervical Disc Prosthesis
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP110009
Supplement NumberS036
Date Received09/05/2024
Decision Date12/02/2024
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
This supplement requested approval for extending shelf life of the LDR Spine Mobi-C® Cervical Disc Prosthesis from 5 years to 10 years.
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