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Soft-tissue anchor, non-bioabsorbable - ARTG 469491

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 registered under ARTG number 469491 and sponsored by Actis Medical Pty Ltd, manufactured by Paragon 28 Inc in United States of America. The device registration started on November 20, 2024.

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 IIb
ARTG 469491
Class IIb
Soft-tissue anchor, non-bioabsorbable
ARTG ID: 469491
Good Name: Actis Medical Pty Ltd - Soft-tissue anchor, non-bioabsorbable
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Intended Purpose

The Grapplerยฎ Interference Screws are PEEK screws that are intended for soft tissue reattachment. The Grapplerยฎ Interference Screw implant is offered in various sizes to accommodate patient anatomy. The device is 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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
469491
Start Date
November 20, 2024
Effective Date
November 20, 2024
Manufacturer
Country
United States of America
Address
14445 Grasslands Drive, Englewood, Colorado, 80112