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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 NamePROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT
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 NumberH980002
Supplement NumberS004
Date Received08/24/2007
Decision Date09/28/2007
Product Code
MPK[ Registered Establishments with MPK ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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