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Fixation anchor, soft-tissue, biodegradable - ARTG 391248

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 registered under ARTG number 391248 and 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.

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TGA ARTG Official Data
Class I
ARTG 391248
Class I
Fixation anchor, soft-tissue, biodegradable
ARTG ID: 391248
Good Name: Smith & Nephew Pty Ltd - Fixation anchor, soft-tissue, biodegradable
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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: โ€ข Rotator cuff tear repairs โ€ข Deltoid repairs

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
ARTG ID
391248
Start Date
June 24, 2022
Effective Date
June 24, 2022
Manufacturer
Country
United States of America
Address
150 Minuteman Road, ANDOVER, MA, 01810