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Ulrich Cervical Plate Systems - Spinal fixation plate, non-biodegradable - ARTG 464109

Access comprehensive regulatory information for Ulrich Cervical Plate Systems - Spinal fixation plate, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 464109 and sponsored by Evolution Surgical Pty Ltd, manufactured by Ulrich GmbH & Co KG in Germany. The device registration started on October 11, 2024.

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.

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Class IIb
ARTG 464109
Class IIb
Ulrich Cervical Plate Systems - Spinal fixation plate, non-biodegradable
ARTG ID: 464109
Good Name: Evolution Surgical Pty Ltd - Ulrich Cervical Plate Systems - Spinal fixation plate, non-biodegradable
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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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464109
Start Date
October 11, 2024
Effective Date
October 11, 2024
Manufacturer
Country
Germany
Address
Buchbrunnenweg 12, Ulm, 89081