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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOPRA™ System
Generic NameOsseoanchored prostheses for the rehabilitation of transfemoral amputees
ApplicantIntegrum AB
Krokslatts Fabriker 50
Mölndal SE-431 37
PMA NumberP190009
Supplement NumberS003
Date Received09/28/2022
Decision Date04/21/2023
Product Code PJY 
Advisory Committee Orthopedic
Clinical TrialsNCT01725711
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the use of additional instruments for use with the OPRA system (i.e., the Abutment InstallationKit, the Abutment Extraction Kit, the Fixture Removal Kit, and the Fractured Abutment/ Abutment ScrewKit).
Post-Approval StudyShow Report Schedule and Study Progress
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