Free

Main information

  • Trade name:
  • Free Gliding SCFE Screw System - Orthopaedic bone screw, non-biodegradable, non-sterile
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Free Gliding SCFE Screw System - Orthopaedic bone screw, non-biodegradable, non-sterile
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218282
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218282

Life Healthcare Pty Ltd - Free Gliding SCFE Screw System - Orthopaedic bone screw, non-biodegradable,

non-sterile

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

9/12/2013

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

Pega Medical Inc

1111 Autoroute Chomedey

Laval, Quebec, H7W5J8

Canada

Products

1. Free Gliding SCFE Screw System - Orthopaedic bone screw, non-biodegradable, non-sterile

Product Type

Medical device system

Effective date

9/12/2013

GMDN

56642 Orthopaedic bone screw, non-biodegradable, non-sterile

Intended purpose

A temporary implant for stabilisation of paediatric femoral neck fractures and slipped capital femoral

epiphysis in all paediatric patients less than 21 years old, with the exclusion of newborn and infants under

2 years of age.

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 10.11.2017 at 11:04:29 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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FDA - U.S. Food and Drug Administration