External lower-limb prosthesis adaptor
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-02-2020
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Available from:
Osseointegration Holdings Pty Ltd
Class:
Class I
Manufactured by:
Osseointegration International BV Spoorstraat 9, AE Ruurlo, 7261 Netherlands
Therapeutic area:
61229 - External lower-limb prosthesis adaptor
Therapeutic indications:
The device is indicated for amputees who are fitted with an osseointegration implant. The system is intended to serve as a means of connecting modular prosthetic limb components to the transcutaneous component of osseointegrated (bone anchored) systems already implanted in the lower limb of an amputee patient.
Authorization status:
A
Authorization date:
2020-01-28
