Australia TGA ARTG record

Spinal fixation plate, non-biodegradable

Australia TGA ARTG Registered Device · Precision Surgical Pty Ltd · Ulrich GmbH & Co KG · Class IIb · Started November 15, 2021

Good Name: Precision Surgical Pty Ltd - Spinal fixation plate, non-biodegradable

Device classification

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

Registration information

Start Date: November 15, 2021
Effective Date: November 15, 2021

Sponsor

Name: Precision Surgical Pty Ltd

Manufacturer

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

Intended purpose

To provide stabilization of the anterior cervical spine (C2 to T1) as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

About this record

Access comprehensive regulatory information for Spinal fixation plate, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Precision Surgical Pty Ltd, manufactured by Ulrich GmbH & Co KG in Germany. The device registration started on November 15, 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.