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Trade Name | OPRA Implant System |
Classification Name | osseoanchored prostheses for the rehabilitation of transfemoral amputees |
Generic Name | osseoanchored prostheses for the rehabilitation of transfemoral amputees |
Applicant |
INTEGRUM AB |
lilla bommen 1 |
goteborg SE-41-411 |
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HDE Number | H080004 |
Supplement Number | S007 |
Date Received | 11/14/2018 |
Decision Date | 03/13/2020 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |