Premarket Approval (PMA)

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.

• Device: Barricaid® Annular Closure Device
• Generic Name: Reherniation reduction device
• Applicant: Intrinsic Therapeutics; 30 Commerce Way; Woburn, MA 01801
• PMA Number: P160050
• Supplement Number: S007
• Date Received: 08/16/2023
• Decision Date: 08/25/2023
• Product Code: QES
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Modification of grip material for the grit blasting step of the Ti64 bone anchor.