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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOPRA
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
Date Received10/20/2008
Decision Date07/16/2015
Product Code
PJY[ Registered Establishments with PJY ]
Docket Number 15M-2584
Notice Date 07/17/2015
Advisory Committee Orthopedic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the osseoanchored prostheses for the rehabilitation of amputees (opra) device. The opra device is indicated for patients who have transfemoral amputation due to trauma or cancer and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The opra device is intended for skeletally mature patients. The patient failed to receive benefit from a socket prostheses due to problems such as: 1) recurrent skin infections and ulcerations in the socket contact area; 2) pain; 3) a short stump preventing the use of socket prosthesis; 4) volume fluctuation in the stump; 5) soft tissue scarring; 6) extensive area of skin grafting; 7) socket retention problems due to excessive perspiration; and 8) restricted mobility.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 
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