Bendini

Main information

  • Trade name:
  • Bendini - Spinal rod bending system
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bendini - Spinal rod bending system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221421
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221421

Nuvasive (Aust/NZ) Pty Ltd - Bendini - Spinal rod bending system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Nuvasive (Aust/NZ) Pty Ltd

Postal Address

PO Box 422,KEW EAST, VIC, 3102

Australia

ARTG Start Date

18/03/2014

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

Nuvasive Inc

7475 Lusk Boulevard

San Diego, CA, 92121

United States Of America

Products

1. Bendini - Spinal rod bending system

Product Type

Medical device system

Effective date

18/03/2014

GMDN

60741 Spinal rod bending system

Intended purpose

The NuVasive Bendini Spinal Rod Bending System is used to locate spinal implant system instrumentation

(screws, hooks) to determine their relative location to one another to generate bend instructions to shape a

spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Spinal Rod

Bender, a mechanical rod bender.

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 01:08:03 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