Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Robot, surgical, operation unit
ARTG entry for
Medical Device Included Class Im
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
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.
120 Columbia Suite 500
Aliso Viejo, CA, 92656
United States Of America
1. Robot, surgical, operation unit
Medical device system
38678 Robotic surgical system
The KneeAlign system is a computer assisted surgery device designed to assist the surgeon in the
alignment of the tibial and femoral cutting guides during total knee arthroplasty. The system consists of the
sterile, single use palm sized navigation unit and associated reusable instrumentation
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:43:07 AEDT
This is not an ARTG Certificate document.
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