Australia TGA ARTG record

Fixation anchor, soft-tissue, biodegradable

Australia TGA ARTG Registered Device · Smith & Nephew Pty Ltd · Smith & Nephew Inc Endoscopy Division · Class I · Started June 24, 2022

Good Name: Smith & Nephew Pty Ltd - Fixation anchor, soft-tissue, biodegradable

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General-Export

Registration information

Start Date: June 24, 2022
Effective Date: June 24, 2022

Sponsor

Name: Smith & Nephew Pty Ltd

Manufacturer

Name: Smith & Nephew Inc Endoscopy Division
Country: United States of America
Address: 150 Minuteman Road, ANDOVER, MA, 01810

Intended purpose

TWINFIX Ultra HA Preloaded Suture Anchors are intended for use only for the reattachment of soft tissue to bone for the following indications: • Rotator cuff tear repairs • Deltoid repairs

About this record

Access comprehensive regulatory information for Fixation anchor, soft-tissue, biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc Endoscopy Division in United States of America. The device registration started on June 24, 2022.

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.