Prosthesis, internal, spine, vertebral body

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Stryker Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
291618

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Public Summary

Summary for ARTG Entry:

291618

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Prosthesis, internal, spine, vertebral body

ARTG entry for

Medical Device Included Class IIb

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

17/07/2017

Product category

Medical Device Class IIb

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

K2M Inc

600 Hope Parkway SE

Leesburg, Virginia, 20175

United States Of America

Products

1. Prosthesis, internal, spine, vertebral body

Product Type

Single Device Product

Effective date

17/07/2017

GMDN

34170 Prosthesis, internal, spine, vertebral body

Intended purpose

The corpectomy cage is a vertebral body replacement device intended for use in the thoracolumbar spine

to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The

corpectomy cage is designed to provide anterior spinal column support even in the absence of fusion for a

prolonged period. The device may be used with allograft or autograft. For all the above indications the

implants are intended to be used with supplemental internal fixation appropriate for the implanted level,

including pedicle screw and hook systems, and spinal plate systems.

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 01.12.2017 at 11:29:48 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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