Summary for ARTG Entry:
Amplitude Australia Pty Ltd - Score cemented resurfacing patellar implant - Polyethylene patella 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. Score cemented resurfacing patellar implant - Polyethylene patella prosthesis
Single Device Product
34199 Polyethylene patella prosthesis
Component of Score total knee prosthesis. The resurfacing patellar implant is made of polyethylene, and is
to be affixed with bone cement.
For use in a total knee prosthesis indicated for primary or secondary osteoarthritis, including revision of an
osteotomy; osteonecrosis; rheumatoid arthritis; post traumatic osteoarthritis; revising unicompartmental or
femoropatellar prostheses; revision arthroplasty.
Diameter (mm) 30-39
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:12:45 AEDT
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