Summary for ARTG Entry:
Amplitude Australia Pty Ltd - SATURNE® Acetabular liner - Non-constrained polyethylene acetabular liner
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. SATURNE® Acetabular liner - Non-constrained polyethylene acetabular liner
Single Device Product
43168 Non-constrained polyethylene acetabular liner
The retentive UHMWPE liner is an insert for the 22.2 or 28mm femoral head and is for use with the
Saturne cemented dual mobility cup, Saturne cementless press-fit dual mobility cup or Saturne cementless
reconstruction dual mobility acetabular cup.
The PE liner is a component of the Saturne acetabular cup intended for a total hip replacement due to
degenerative or congenital inflammatory or post traumatic causes; sequelae from previous interventions,
THR, osteotomy or arthrodesis.
Diameter (mm) 22-28 inner diameter
Diameter (mm) 44-66 external diameter
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:02:44 AEDT
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