Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS002
Date Received08/10/2023
Decision Date09/07/2023
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  
Information provided by the firm to support the following changes: 1. The addition of two (2) semi-automated assembly machines (Boot to TOP Plate machine-EGEQ88244 and Core Assembly to TOP Plate-EGEQ88242), as alternative to the current manual process, for certain assembly steps of the TOPS; and 2) Flip the insertion orientation of the Polycarbonate Urethane (PcU) Plug prior to its insertion into the TOPS Top Plate.
-
-