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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 NumberS002
Date Received11/09/2015
Decision Date10/28/2016
Product Code
PJY[ Registered Establishments with PJY ]
Advisory Committee Orthopedic
Clinical Trials NCT01725711
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for design and material changes to the abutment, fixture, abutment screw, central screw, and healing components. A new manufacturing facility is also being requested for approval: laser nova, ab odenskogsvagen 1a, ostersund 831 48, sweden.
Labeling Labeling
Labeling Part 2
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