Metal-polymer composite spinal fusion cage

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Nuvasive (Aust/NZ) Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
339450

Public Summary

Summary for ARTG Entry:

339450

Nuvasive (Aust/NZ) Pty Ltd - Metal-polymer composite spinal fusion cage

ARTG entry for

Medical Device Included Class IIb

Sponsor

Nuvasive (Aust/NZ) Pty Ltd

Postal Address

PO Box 422, KEW EAST, VIC, 3102

Australia

ARTG Start Date

14/07/2020

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

Nuvasive Inc

7475 Lusk Boulevard

San Diego, CA, 92121

United States Of America

Products

1 . Metal-polymer composite spinal fusion cage

Product Type

Single Device Product

Effective Date

14/07/2020

GMDN

61230 Metal-polymer composite spinal fusion cage

Intended Purpose

NuVasive interbody system are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is

designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to

facilitate fusion and supplemental internalspinal fixation systems for use in the thoracolumbar spine.

The systems are intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction

(T12-L1). The system implants are also intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc

disease or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation The interbody systems

can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

When used in the cervical spine, the interbody implants are indicated for intervertebral body fusion of the spine in skeletally mature

patients. The cervical interbody systems are intended for use for anterior cervical interbody fusion in patients with cervical disc

degeneration and/or cervical spinal instability, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels

from C2-T1. The system is intended to be used with or without supplemental fixation. The System is designed for use with

autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate 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 22.07.2020 at 09:29:52 AEST

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

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