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Spinal fixation plate, non-biodegradable

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Spinal fixation plate, non-biodegradable
Australia TGA ARTG Registered Device
Good Name: Precision Surgical Pty Ltd - 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
Start Date
November 15, 2021
Effective Date
November 15, 2021
Manufacturer
Country
Germany
Address
Buchbrunnenweg 12, Ulm, 89081