Australia TGA ARTG record

Bone-screw internal spinal fixation system, non-sterile

Australia TGA ARTG Registered Device · Evolution Surgical Pty Ltd · Ulrich GmbH & Co KG · Class IIb · Started May 10, 2021

Good Name: Evolution Surgical Pty Ltd - Bone-screw internal spinal fixation system, non-sterile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 10, 2021
Effective Date: May 10, 2021

Sponsor

Name: Evolution Surgical Pty Ltd

Manufacturer

Name: Ulrich GmbH & Co KG
Country: Germany
Address: Buchbrunnenweg 12, Ulm, 89081

Intended purpose

The ulrich Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, the device is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and failed previous fusion.

About this record

Access comprehensive regulatory information for Bone-screw internal spinal fixation system, non-sterile 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 Ulrich GmbH & Co KG in Germany. The device registration started on May 10, 2021.

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.