Summary for ARTG Entry:
Medacta Australia Pty Ltd - Dispenser, cement, orthopaedic
ARTG entry for
Medical Device Included Class IIa
Medacta Australia Pty Ltd
Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066
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.
Summit Medical Ltd
Bourton on the Water Chelstenham,
Gloucestershire, GL54 2HQ
1. Dispenser, cement, orthopaedic
35809 Dispenser, cement, orthopaedic
Bone cement mixing and delivery system with femoral cement pressuriser intended for use in placing
orthopaedic bone cement into surgical sites. This is a single-use device.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 07:02:57 AEDT
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