Summary for ARTG Entry:
Amplitude Australia Pty Ltd - ANATOMIC® tibial base plate HA coated, Cementless - Coated knee tibia
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 HA coated, Cementless - Coated knee tibia prosthesis
Single Device Product
34198 Coated knee tibia prosthesis
The tibial base plate is for cementless application and is made from cobalt chrome with HAP coating in
combination with a titanium undercoating. The device is symmetrical is design and as such can be used
for both left and right side. The highly polished contact surface reduces backside wear.
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 09:11:33 AEDT
This is not an ARTG Certificate document.
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