Ligament anchor

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

Buy It Now

Available from:
Medacta Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
290767

Read the complete document

Public Summary

Summary for ARTG Entry:

290767

Medacta Australia Pty Ltd - Ligament anchor

ARTG entry for

Medical Device Included Class IIb

Sponsor

Medacta Australia Pty Ltd

Postal Address

Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

28/06/2017

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

Medacta International SA

Strada Regina

, Castel San Pietro, CH-6874

Switzerland

Products

1. Ligament anchor

Product Type

Single Device Product

Effective date

28/06/2017

GMDN

36174 Ligament anchor

Intended purpose

The Pull Suture Plate is used for the tibial fixation of the implanted cruciate ligament replacement graft

during the reconstructive treatment of cruciate ligament ruptures. The Pull Suture Plate is intended for

reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous

grafts.

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 03.11.2017 at 02:53:44 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

Search alerts related to this product

Share this information