Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Merit Medical Australia Pty Ltd - Orthopaedic cement preparation/delivery kit
ARTG entry for
Medical Device Included Class IIb
Merit Medical Australia Pty Ltd
Unit 44 - 328 Reserve Road,Cheltenham, VIC, 3192
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.
Merit Medical Systems Inc
1600 West Merit Parkway
South Jordan, UTAH, 84095
United States Of America
1. Orthopaedic cement preparation/delivery kit
Medical device system
45253 Orthopaedic cement preparation/delivery kit
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER2 Bone
Cement in vertebroplasty/kyphoplasty procedures in the treatment of pathological fractures of the
vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions
(hemangioma), and malignant lesions (metastatic cancers, myeloma).
No Specific Conditions included on Record
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Produced at 03.11.2017 at 12:41:56 AEDT
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