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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.
Classification Nameprosthesis, finger, constrained, metal/polymer
Generic Nameprosthesis, finger, constrained, metal/polymer
Regulation Number888.3220
bohnackerweg 1
selzach CH 25
PMA NumberP960053
Supplement NumberS002
Date Received04/16/1998
Decision Date06/04/1998
Product Code
KWG[ Registered Establishments with KWG ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) packaging the implant in a single box containing both the proximal and distal components and changing package labels accordingly, and 2) changing the color of stock used for printing box labels.