Summary for ARTG Entry:
Stryker Australia Pty Ltd - Mobile-bearing total ankle prosthesis
ARTG entry for
Medical Device Included Class IIb
Stryker Australia Pty Ltd
PO Box 970,ARTARMON, NSW, 1570
ARTG Start Date
Medical Device Class IIb
- 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.
Small Bone Innovations Inc
1380 South Pennsylvania Avenue
Morrisville, PA, 19067
United States Of America
1. Mobile-bearing total ankle prosthesis
Single Device Product
33582 Mobile-bearing total ankle prosthesis
A device to replace the primary articulation bearing surface of the ankle. It includes tibial and talar
components, with parts made of metal (cobalt chromium alloy, titanium) and polyethylene (PE). It may be
non-constrained, constrained or semi-constrained. Implantation may be performed with or without bone
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:47:03 AEDT
This is not an ARTG Certificate document.
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