Fixation

Main information

  • Trade name:
  • Fixation system, internal, spinal, bone screw
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Fixation system, internal, spinal, bone screw
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221268
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221268

Precision Surgical Pty Ltd - Fixation system, internal, spinal, bone screw

ARTG entry for

Medical Device Included Class IIb

Sponsor

Precision Surgical Pty Ltd

Postal Address

Unit 10 / 9-11 Myrtle Street,Crows Nest, NSW, 2065

Australia

ARTG Start Date

14/03/2014

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

Yellowsteps

161 avenue Franklin Roosevelt

Decines, , 69150

France

Products

1. Fixation system, internal, spinal, bone screw

Product Type

Medical device system

Effective date

14/03/2014

GMDN

43257 Fixation system, internal, spinal, bone screw

Intended purpose

A bone screw spinal implant assembly that consists of pedicle screws, longitudinal and tranverse

interconnecting plates, intended to provide immobilization and stabilization of spinal segments in the

treatment of various spinal instabilities or deformities.

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 01:34:15 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