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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.
 
DeviceTOUCH® CMC 1 Prosthesis
Generic NameProsthesis, finger, semi-constrained, metal/polymer
ApplicantKeri Medical SA
Chemin Du Pre-Fleuri 5
1228 Plan-Les-Ouates 
PMA NumberP240020
Supplement NumberS005
Date Received03/13/2026
Decision Date04/13/2026
Product Code SFA 
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  
approval for the addition of new sealing equipment at two existing manufacturing sites.
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