Australia TGA ARTG record

Spinal internal fixation system, intervertebral body

Australia TGA ARTG Registered Device · Evolution Surgical Pty Ltd · Cousin Biotech SAS · Class IIb · Started March 22, 2016

Good Name: Evolution Surgical Pty Ltd - Spinal internal fixation system, intervertebral body

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: March 22, 2016
Effective Date: March 22, 2016

Sponsor

Name: Evolution Surgical Pty Ltd

Manufacturer

Name: Cousin Biotech SAS
Country: France
Address: 8 Rue De L'Abbe Bonpain, Wervicq-Sud, 59117

Intended purpose

This ligament correction system is an implant dedicated to the correction and stabilization of the spine during fusion. It is indicated for the following surgical treatments: - Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions.

About this record

Access comprehensive regulatory information for Spinal internal fixation system, intervertebral body in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Evolution Surgical Pty Ltd, manufactured by Cousin Biotech SAS in France. The device registration started on March 22, 2016.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.