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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
Applicant
Integrum AB
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.
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