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GRAPPLER® Suture Anchor R3FLEX IOL System - Soft-tissue anchor, non-bioabsorbable - ARTG 469490

Access comprehensive regulatory information for GRAPPLER® Suture Anchor R3FLEX IOL System - 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 469490 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 469490
Class IIb
GRAPPLER® Suture Anchor R3FLEX IOL System - Soft-tissue anchor, non-bioabsorbable
ARTG ID: 469490
Good Name: Actis Medical Pty Ltd - GRAPPLER® Suture Anchor R3FLEX IOL System - Soft-tissue anchor, non-bioabsorbable
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Intended Purpose

The Grappler® Suture Anchor R3FLEX IOL System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and all-suture and are connected by suture composed of UHMWPE.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
469490
Start Date
November 20, 2024
Effective Date
November 20, 2024
Manufacturer
Country
United States of America
Address
14445 Grasslands Drive, Englewood, Colorado, 80112