Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Ultra-Drive - Extractor, cement, orthopaedic
ARTG entry for
Medical Device Included Class IIa
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class IIa
- 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.
Biomet Orthopedics also T/A Biomet Sports
Medicine /Biomet Biologics /Biomet Trauma
56 East Bell Drive PO Box 587
Warsaw, Indiana, 56581
United States Of America
1. Ultra-Drive - Extractor, cement, orthopaedic
Medical device system
37065 Extractor, cement, orthopaedic
The Ultradrive 3 is indicated for cutting and removal of bone and acrylic bone cement in orthopedic
applications. The Ultra-Drive 3 consists of a control console, a footswitch, a
handpiece with associated cables. The system is intended to be used with disposable accessories.
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Produced at 02.11.2019 at 05:54:57 AEDT
This is not an ARTG Certificate document.
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