Summary for ARTG Entry:
Tornier Pty Ltd - Orthopaedic implantation application software
ARTG entry for
Medical Device Included Class Im
Tornier Pty Ltd
PO Box 230,BELROSE, NSW, 2085
ARTG Start Date
Medical Device Class Im
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
65 Place Copernic
, Plouzane, 29280
1. Orthopaedic implantation application software
Single Device Product
46470 Orthopaedic implantation application software
Software used pre-operatively as a planning tool to determine the size and positioning of prosthetic
components in relation to anatomical landmarks based on CT images of the patient. Patient-specific
(custom) guides based on the preoperative planning may be subsequently generated.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:17:48 AEDT
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