Summary for ARTG Entry:
Amplitude Australia Pty Ltd - ANATOMIC® tibial base plate, cemented - Uncoated knee tibia prosthesis,
ARTG entry for
Medical Device Included Class III
Amplitude Australia Pty Ltd
Level 7/263 Clarence Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class III
- 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.
11 Cours Offenbach
Valence, , 26000
1. ANATOMIC® tibial base plate, cemented - Uncoated knee tibia prosthesis, metallic
Single Device Product
32832 Uncoated knee tibia prosthesis, metallic
The tibial base plate is for cemented application and is made from cobalt chrome. The highly polished
contact surface reduces backside wear.The base plate is designed to articulate with a fixed bearing insert.
The tibial base plate is a component of the ANATOMIC Total Knee System that is indicated for Primary or
secondary osteoarthritis, including revision of an osteotomy; Osteonecrosis;Rheumatoid arthritis;
Post-traumatic osteoarthritis; Primary TKP is indicated for revising unicompartmental or femoropatellar
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:11:17 AEDT
This is not an ARTG Certificate document.
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