Gender

Main information

  • Trade name:
  • Gender Solutions™ Natural-Knee® Flex System Gender Solutions Female (GSF), Sinterlock Porous Coated, Femoral Component - Prosthe
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Gender Solutions™ Natural-Knee® Flex System Gender Solutions Female (GSF), Sinterlock Porous Coated, Femoral Component - Prosthe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222232
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222232

Zimmer Pty Ltd - Gender Solutions™ Natural-Knee® Flex System Gender Solutions Female (GSF),

Sinterlock Porous Coated, Femoral Component - Coated knee femur prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

9/04/2014

Product category

Medical Device Class III

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

Zimmer Inc

1800 West Center Street

WARSAW, INDIANA, 46580

United States Of America

Products

1. Gender Solutions™ Natural-Knee® Flex System Gender Solutions Female (GSF), Sinterlock Porous

Coated, Femoral Component - Prosthesis, inter - Coated knee femur prosthesis

Product Type

Single Device Product

Effective date

9/04/2014

GMDN

33745 Coated knee femur prosthesis

Functional description

Designed to have a maximum active flexion of 155 degrees, they are porous coated femoral components

of the semiconstrained total knee The Gender Solutions Natural-Knee Flex System (N-K Flex)System and

are made from Zimaloy® Cobalt-Chromium-Molybdenum Alloy, with a Cancellous-Structured Titanium™

(CSTi™) porous coating. They are for uncemented or cemented use.

Intended purpose

Porous coated femoral components of the the Gender Solutions Natural-Knee Flex(N-K

Flex)semiconstrained total knee System intended for use in skeletally mature individuals with intact medial

and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of

Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

Variant information

Size 0 - 4

Shape Left

Shape Right

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 10:17:58 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

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

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