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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.
 
DeviceSynergy Disc
Generic NameProsthesis, intervertebral disc
ApplicantSynergy Spine Solutions, Inc.
357 S. Mccaslin Blvd., Suite 120
Louisville, CO 80027
PMA NumberP250028
Supplement NumberS003
Date Received06/25/2026
Decision Date09/17/2026
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
packaging materials changes and the addition of a secondary packaging configuration
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