Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Surgical instrument handle
ARTG entry for
Medical Device Included Class 1
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class 1
- 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.
ZimmerBiomet Spine Inc
10225 Westmoor Drive
Westminster, CO, 80021
United States Of America
1. Surgical instrument handle
Single Device Product
47829 Surgical instrument handle
A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument to
allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw
or tensioning of a nut during a surgical procedure.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:45:35 AEDT
This is not an ARTG Certificate document.
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