CarboFix

Main information

  • Trade name:
  • CarboFix - Piccolo Composite Plate System - Orthopaedic fixation plate, non-biodegradable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CarboFix - Piccolo Composite Plate System - Orthopaedic fixation plate, non-biodegradable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222648
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222648

JOI Orthopaedics Pty Ltd - CarboFix - Piccolo Composite Plate System - Orthopaedic fixation plate,

non-biodegradable

ARTG entry for

Medical Device Included Class IIb

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 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

CarboFix Orthopedics Ltd

11 Ha'hoshlim Street

, Herzeliya, 46724

Israel

Products

1. CarboFix - Piccolo Composite Plate System - Orthopaedic fixation plate, non-biodegradable

Product Type

Medical device system

Effective date

17/04/2014

GMDN

46647 Orthopaedic fixation plate, non-biodegradable

Intended purpose

An implantable sheet of firm material (continuous carbon fibre reinforced polymer) that is attached to

fractured bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from

stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes.

The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to

temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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 08:41:17 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