Australia TGA ARTG record

Soft-tissue anchor, non-bioabsorbable

Australia TGA ARTG Registered Device · Actis Medical Pty Ltd · Paragon 28 Inc · Class IIb · Started July 12, 2023

Good Name: Actis Medical Pty Ltd - Soft-tissue anchor, non-bioabsorbable

Device classification

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

Registration information

Start Date: July 12, 2023
Effective Date: July 12, 2023

Sponsor

Name: Actis Medical Pty Ltd

Manufacturer

Name: Paragon 28 Inc
Country: United States of America
Address: 14445 Grasslands Drive, Englewood, Colorado, 80112

Intended purpose

An anchor intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist.

About this record

Access comprehensive regulatory information for Soft-tissue anchor, non-bioabsorbable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Actis Medical Pty Ltd, manufactured by Paragon 28 Inc in United States of America. The device registration started on July 12, 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.