Soft-tissue anchor, non-bioabsorbable

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

Buy It Now

Available from:
Smith & Nephew Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
322940

Public Summary

Summary for ARTG Entry:

322940

Smith & Nephew Pty Ltd - Soft-tissue anchor, non-bioabsorbable

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670

Australia

ARTG Start Date

10/09/2019

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

Ceterix Orthopaedics Inc

6500 Kaiser Drive Suite 120

Fremont, CA, 94555

United States Of America

Products

1. Soft-tissue anchor, non-bioabsorbable

Product Type

Single Device Product

Effective date

10/09/2019

GMDN

45062 Soft-tissue anchor, non-bioabsorbable

Intended purpose

The NovoStitch Pro Meniscal Repair System is intended for approximation of soft tissue in meniscal repair

procedures.

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 02.11.2019 at 04:41:10 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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