Global

Main information

  • Trade name:
  • Global Ceramic Head - Ceramic femoral head prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Global Ceramic Head - Ceramic femoral head prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218812
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218812

Global Orthopaedic Technology Pty Ltd - Global Ceramic Head - Ceramic femoral head prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Global Orthopaedic Technology Pty Ltd

Postal Address

PO Box 7745,BAULKHAM HILLS, NSW, 2153

Australia

ARTG Start Date

24/12/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Global Manufacturing Technology Europe Ltd

15 Rudchesters Bancroft

, Milton Keynes, MK13 0PH

Products

1. Global Ceramic Head - Ceramic femoral head prosthesis

Product Type

Single Device Product

Effective date

24/12/2013

GMDN

38156 Ceramic femoral head prosthesis

Functional description

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.

Intended purpose

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.

Variant information

Offset -3.5 to +7

Size 28-40

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 09:14:48 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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