Custom-made orthopaedic surgical guide, non-sterile
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
21-04-2021
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Available from:
AA-Med Pty Ltd
Class:
Class I
Manufactured by:
Lyka Smith Pty Ltd 1B/40-52 McArthurs Road, Altona North, VIC, 3025 Australia
Therapeutic area:
60826 - Custom-made orthopaedic surgical guide, non-sterile
Therapeutic indications:
Custom made dental drilling guide designed to fit a specific patient and are intended to be used as surgical tools to transfer a pre-operative plan to surgery. These Guides are intended to guide the marking of bone and/or guide surgical instruments in dental procedures. The Guides are intended for single use only.
Authorization status:
A
Authorization date:
2021-03-09
