Summary for ARTG Entry:
Global Orthopaedic Technology Pty Ltd - Global Ceramic Head - Ceramic femoral head prosthesis
ARTG entry for
Medical Device Included Class III
Global Orthopaedic Technology Pty Ltd
PO Box 7745,BAULKHAM HILLS, NSW, 2153
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.
Global Manufacturing Technology Europe Ltd
15 Rudchesters Bancroft
, Milton Keynes, MK13 0PH
1. Global Ceramic Head - Ceramic femoral head prosthesis
Single Device Product
38156 Ceramic femoral head prosthesis
The device is intended to be attached to the trunnion end of a prosthetic femoral hip stem, and to articulate
with the acetabulum or the inner surface of an acetabular prosthesis.
The device is a ceramic femoral head used as the replacement of a diseased or damaged femoral head in
total hip arthroplasty, or to revise a previously implanted prosthesis. The device is intended to be attached
to the trunnion of a femoral stem prosthesis, and articulate with the acetabulum, or inner surface of an
acetabular prosthesis. It is supplied sterile, and is intended for single use only.
Offset -3.5 to +7
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:14:48 AEDT
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