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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 NumberS005
Date Received12/19/2024
Decision Date01/17/2025
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  
Change to introduce three (3) semi-automated machines as alternatives to the current manual process for certain TOPS™ assembly steps at the established manufacturing facility in Netanya, Israel for enhanced reproducibility / reliability
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