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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.
 
DeviceTOPS™ System
Generic NameProsthesis, posterior spinal elements
ApplicantPremia Spine, Ltd.
7 Giborey Israel St.
Ramat Poleg
Netanya 4250407
PMA NumberP220002
Supplement NumberS011
Date Received08/10/2026
Decision Date09/09/2026
Product Code QWK 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of an additional subcontractor for the manufacturing of pedicle screw components to be used with the TOPS™ implant - Triangle Manufacturing Co., Inc.
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