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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.
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 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