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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 NumberS009
Date Received08/18/2025
Decision Date05/29/2026
Product Code QWK 
Advisory Committee Orthopedic
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 the addition of a new inserter (TOPS™ 2 inserter) and implant design variant (TOPS™ 2) to be included in the TOPS™ System
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