Custom-made orthopaedic surgical guide, non-sterile

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

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Available from:
Omni Melbourne
Class:
Class 1
Authorization status:
Included
Authorization number:
323177

Public Summary

Summary for ARTG Entry:

323177

Omni Melbourne - Custom-made orthopaedic surgical guide, non-sterile

ARTG entry for

Medical Device Included Class 1

Sponsor

Omni Melbourne

Postal Address

40-42 Isabella Street,Moorabbin, VIC, 3189

Australia

ARTG Start Date

13/09/2019

Product category

Medical Device Class 1

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

Omni Melbourne

40-42 Isabella Street

Moorabbin, VIC, 3189

Australia

Products

1. Custom-made orthopaedic surgical guide, non-sterile

Product Type

Single Device Product

Effective date

13/09/2019

GMDN

60826 Custom-made orthopaedic surgical guide, non-sterile

Intended purpose

This is a device that contains 3 surgical guides that have been custom made, patient specific and single

use as a result of being prepared via a 3-D printing technique using CAD/CAM technologies.

These surgical guides have been specifically designed as an integral single-use device that are intended

to be used for locating the anchor pins as part of customising the AuDentes prosthetic Bridge, guiding the

osteotomy of the maxilla and/or mandible as well as implanting the dental prosthetic devices which

permanently retain the bridge.

Specific Conditions

© 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 08.11.2019 at 10:43:48 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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