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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 (Two Level)
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP110009
Supplement NumberS033
Date Received02/15/2022
Decision Date01/12/2023
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for qualifying alternative detergents Deconex MT12 & MT13 used for cleaning of the Mobi-C implant and a sub-supplier change to KEYBIO.
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