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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 NumberS004
Date Received12/23/2016
Decision Date06/20/2017
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes to the surgical technique and for the addition of the Class III activL® Slim Trial Instruments and the activL® Artificial Disc Ancillary Trialing & Confirmation instrument tray to the system
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