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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 NumberS003
Date Received11/08/2002
Decision Date12/31/2002
Product Code
MPK[ Registered Establishments with MPK ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a new manufacturing facility located at rms co. , 8600 evergreen blvd. , minneapolis, minnesota 55433-6036 and a new sterilization facility located at micronet medical, inc. , 1839 buerkle road, st. Paul, mn.
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