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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 NameOPRA Implant System
Classification Nameosseoanchored prostheses for the rehabilitation of transfemoral amputees
Generic Nameosseoanchored prostheses for the rehabilitation of transfemoral amputees
lilla bommen 1
goteborg SE-41-411
HDE NumberH080004
Supplement NumberS007
Date Received11/14/2018
Decision Date03/13/2020
Product Code
PJY[ Registered Establishments with PJY ]
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 manufacturing site for willo ab, located at stora räppevagen 61växjö, kronobergs lan, 352 50, sweden, for the manufacture of the axor ii.