Samarys

Main information

  • Trade name:
  • Samarys RF - Spinal cage
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Samarys RF - Spinal cage
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220085
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220085

Scientx Australia - Samarys RF - Spinal cage

ARTG entry for

Medical Device Included Class III

Sponsor

Scientx Australia

Postal Address

1/575 Darling Street,ROZELLE, NSW, 2039

Australia

ARTG Start Date

12/02/2014

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

Kasios SAS

18 chemin de la Violette

L'union, , 31240

France

Products

1. Samarys RF - Spinal cage

Product Type

Single Device Product

Effective date

12/02/2014

GMDN

38161 Spinal cage

Functional description

SAMARYS RF is a cervical cage, pre-filled with a synthetic bone substitute and pre-loaded on a

disposable cage inserter ancillary. The pre-filled cervical cage is designed to be implanted into

intervertebral spaces when performing intersomatic cervical arthrodesis. When the assembly is delivered,

the stainless steel insertion ancillary is already screwed onto the prefilled cage. This facilitates the surgical

procedure and also makes it possible to insert a pre-filled cage.

Intended purpose

The Samarys RF is intended for use in anterior approach cervical fusion, in order to optimize bone fusion

at levels C3 to C7. It is indicated for:

- stabilization after curettage in the event of cervical disc herniation or compressive osteophytosis affecting

the nerve roots and/or the spinal cord

- degenerative intervertebral instability

The implant (cage + bone substitute) is useful, in particular,to achieve radicular decompression by

intersomatic distraction.

Variant information

Length (mm) 12 to 15 (also known as depth)

Width (mm) 15-20

Height (mm) 4.5 to 10

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 05:22:52 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