Memory-alloy

Public Summary

Summary for ARTG Entry:

218346

Life Healthcare Pty Ltd - Memory-alloy orthopaedic fixation plate

ARTG entry for

Medical Device Included Class IIb

Sponsor

Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

10/12/2013

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

Biopro Inc

17 Seventeenth Street

PORT HURON, MICHIGAN, 48060

United States Of America

Products

1. Memory-alloy orthopaedic fixation plate

Product Type

Single Device Product

Effective date

10/12/2013

GMDN

58235 Memory-alloy orthopaedic fixation plate

Intended purpose

Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.

Specific Conditions

No Specific Conditions included on Record

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Public Summary

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Produced at 10.11.2017 at 10:48:15 AEDT

This is not an ARTG Certificate document.

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