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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameMETACARPOPHALANGEAL (MCP) JOINT IMPLANT FINGER PROSTHESIS
Classification Namesemi-constrained metal/polymer finger joint prosthesis
Generic Namesemi-constrained metal/polymer finger joint prosthesis
Applicant
Encore Medical L/P. D/B/A Djo Surgical
9800 metric blvd.
austin, TX 78758
HDE NumberH010001
Supplement NumberS003
Date Received04/01/2016
Decision Date06/14/2016
Product Code
MPK[ Registered Establishments with MPK ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to changes to the device labeling and a trade name change.
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