Orthopaedic bone staple, non-adjustable, sterile

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

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIb
Authorization status:
Included
Authorization number:
291681

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Public Summary

Summary for ARTG Entry:

291681

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Orthopaedic bone staple, non-adjustable, sterile

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

18/07/2017

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

Paragon 28 Inc

4B Inverness Ct East Suite 280

Englewood, Colorado, 80112

United States Of America

Products

1. Orthopaedic bone staple, non-adjustable, sterile

Product Type

Medical device system

Effective date

18/07/2017

GMDN

61669 Orthopaedic bone staple, non-adjustable, sterile

Intended purpose

The system is indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of

the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted

to the extent to preclude staple placement) located in the long bones of the lower extremities such as the

fibula and tibia.

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 11:29:00 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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