Bone-screw internal spinal fixation system, non-sterile - ARTG 365230
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 registered under ARTG number 365230 and 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.
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.