Bone-screw

Main information

  • Trade name:
  • Bone-screw internal spinal fixation system, non-sterile
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bone-screw internal spinal fixation system, non-sterile
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216458
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216458

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Bone-screw internal spinal fixation system, non-sterile

ARTG entry for

Medical Device Included Class IIb

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

23/10/2013

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

Spinecraft

777 Oakmont Lane

Westmont, IL, 60559

United States Of America

Products

1. Bone-screw internal spinal fixation system, non-sterile

Product Type

Medical device system

Effective date

23/10/2013

GMDN

61325 Bone-screw internal spinal fixation system, non-sterile

Intended purpose

The system consists of longitudinal rods, pedicle screws, cannulated pedicle screws, hooks, lateral

connectors and transverse connectors. The system is intended to provide immobilization and stabilization

of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following

acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe

spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective

evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed

previous fusion (pseudo-arthrosis). The system is also indicated for pedicle screw fixation for the treatment

of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving

fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of

pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after fusion is

attained. The system is also a hook and sacral/iliac screw fixation system of the non-cervical spine

indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc

confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation),

spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion. The

system is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease

(defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic

studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis,

kyphosis, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature

patients. Levels of fixation are for the thoracic, lumbar and sacral spine.

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 02.12.2017 at 05:06:56 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

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