Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
03-11-2017
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Available from:
Orthotech Pty Ltd
Class:
Class IIb
Manufactured by:
Beijing Fito Lanvie Medical Device Co Ltd 3# South 3rd Street Yanqi Development Zone Huairou, Beijing, 101407 China
Therapeutic area:
61573 - Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Therapeutic indications:
The metal bone plate is non-sterile implantable device made from titanium alloy, intended for internal bone fixation of bone fractures, fusions or osteotomies during orthopaedic procedures. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).
Authorization status:
A
Authorization date:
2017-03-23
