Leg internal-external prosthesis intrafemoral bar
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
11-11-2017
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Available from:
Surgien Pty Ltd
Class:
Class I
Manufactured by:
Integrum AB Krokslatts Fabriker 50, Molndal, SE-431 37 Sweden
Therapeutic area:
58743 - Leg internal-external prosthesis intrafemoral bar
Therapeutic indications:
OPRA Axor is a medical device intended to connect the Osseointegration OPRA System to external prosthetic components.It is designed to protect the OPRA system from high mechanical forces and also to avoid any skeletal fracture caused by an accident situation. The function is to limit rotational forces in the centre line of the Osseointegration OPRA System and bending forces when the prosthetic knee is bent to its max position.
Authorization status:
A
Authorization date:
2013-02-12
