Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Coated hip femur prosthesis, modular
ARTG entry for
Medical Device Included (Export Only) 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.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. Coated hip femur prosthesis, modular
Single Device Product
33581 Coated hip femur prosthesis, modular
Replacement of femoral hip stem. The ZMR prosthesis is supplied under this inclusion. The ZMR modular
stem exclusive of the XL component is not intended for cementless total arthroplasty in patients whose
bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies
of the femoral head, neck, or portions of the proximal femur.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 07:20:22 AEDT
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