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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.
 
DeviceactivL Artificial Disc
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP120024
Supplement NumberS014
Date Received10/31/2025
Decision Date01/29/2026
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the Olive Branch Distribution Center (FEI 3016050940) as an additional facility for conducting incoming product inspections, Device History Record (DHR) documentation review, and release of finished goods into inventory for distribution of the subject device to the United States market.
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