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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.
 
DeviceBRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
Generic NameProsthesis, finger, constrained, metal/polymer
Regulation Number888.3220
ApplicantStryker Corporation
Bohnackerweg 1
Selzach CH 2545
PMA NumberP960053
Supplement NumberS005
Date Received07/13/2016
Decision Date08/09/2016
Product Code KWG 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of changes to the device labeling.
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