CarboFix

Main information

  • Trade name:
  • CarboFix Instrument Kits - Fixation system implantation kit, internal
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CarboFix Instrument Kits - Fixation system implantation kit, internal
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222649
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222649

JOI Orthopaedics Pty Ltd - CarboFix Instrument Kits - Fixation system implantation kit, internal

ARTG entry for

Medical Device Included Class IIa

Sponsor

JOI Orthopaedics Pty Ltd

Postal Address

44 Iffla Street,South Melbourne, VIC, 3205

Australia

ARTG Start Date

17/04/2014

Product category

Medical Device Class IIa

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

CarboFix Orthopedics Ltd

11 Ha'hoshlim Street

, Herzeliya, 46724

Israel

Products

1. CarboFix Instrument Kits - Fixation system implantation kit, internal

Product Type

Medical device system

Effective date

17/04/2014

GMDN

44759 Fixation system implantation kit, internal

Intended purpose

A collection of instruments used for the placement of an internal fixation system into or onto bone or bones

that may involve internal fixation (e.g., bones of limbs, spine, pelvis, craniomaxillofacia). The instruments

include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws,

screwdrivers, guides, trials, impactors) that are specific to the internal fixation system applied.

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 09.11.2017 at 08:41:02 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