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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.
 
DeviceBarricaid® Annular Closure Device
Generic NameReherniation reduction device
ApplicantIntrinsic Therapeutics
30 Commerce Way
Woburn, MA 01801
PMA NumberP160050
Supplement NumberS010
Date Received02/03/2025
Decision Date10/09/2025
Product Code QES 
Advisory Committee Orthopedic
Clinical TrialsNCT03366779
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a new 6mm baseplate sized implant.
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