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Bone-screw internal spinal fixation system, non-sterile

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 Equinox Medical Pty Ltd, manufactured by Shandong Weigao Orthopaedic Device Company Limited. in China. The device registration started on February 25, 2020.

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
Bone-screw internal spinal fixation system, non-sterile
Australia TGA ARTG Registered Device
Good Name: Equinox Medical Pty Ltd - Bone-screw internal spinal fixation system, non-sterile
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DJ Fang

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Intended Purpose

The device is indicated for spinal fixation including: 1) Degenerative diseases (eg, disc herniation, spinal stenosis, spondylolisthesis, lumbar instability); 2) Spinal deformities (eg, scoliosis, humpback and / or lordosis); 3) trauma (eg, fracture, and / or dislocation); 4) pseudarthrosis, tumor resection, and / or previous fusion fails.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 25, 2020
Effective Date
February 25, 2020
Manufacturer
Country
China
Address
No 26 Xiangjiang Road Tourist Resorts, Weihai City, Shandong, 264203