Australia TGA ARTG record

Healicoil Knotless Regenesorb Suture Anchor - Fixation anchor, soft-tissue, biodegradable

Australia TGA ARTG Registered Device · Smith & Nephew Pty Ltd · Smith & Nephew Inc Endoscopy Division · Class III · Started January 07, 2022

Good Name: Smith & Nephew Pty Ltd - Healicoil Knotless Regenesorb Suture Anchor - Fixation anchor, soft-tissue, biodegradable

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 07, 2022
Effective Date: January 07, 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, 01810-1031

Intended purpose

HEALICOIL Knotless REGENESORB Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications: Shoulder -Biceps tenodesis -Rotator cuff tear repair

About this record

Access comprehensive regulatory information for Healicoil Knotless Regenesorb Suture Anchor - Fixation anchor, soft-tissue, biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Smith & Nephew Pty Ltd, manufactured by Smith & Nephew Inc Endoscopy Division in United States of America. The device registration started on January 07, 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.