Australia flagARTG 408355

Orthopaedic bone screw, non-biodegradable, non-sterile

ARTG ID: 408355 · Lyka Smith Pty Ltd · Jiangsu Shuangyang Medical Instrument Co Ltd · Class IIb · Started May 02, 2023

Good Name: Lyka Smith Pty Ltd - Orthopaedic bone screw, non-biodegradable, non-sterile

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
408355
Start Date
May 02, 2023
Effective Date
May 02, 2023
Sponsor
Manufacturer
Country
China
Address
Shuangyang Building Baoji, Zhangjiagang, Jiangsu, 215600
Intended purpose

Titanium bone screw is used for cranial, maxillofacial, clavicle, limp diaphyseal and epiphyseal, pelvic, metacarpal and phalange, and calcaneus fractures.

About this record

Access comprehensive regulatory information for Orthopaedic bone screw, non-biodegradable, 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 408355 and sponsored by Lyka Smith Pty Ltd, manufactured by Jiangsu Shuangyang Medical Instrument Co Ltd in China. The device registration started on May 02, 2023.

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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