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Soft-tissue anchor, non-bioabsorbable - ARTG 352376

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 352376 and sponsored by Australian Orthopaedic Fixations Pty Ltd, manufactured by Aleda Makina San Dis Tic Ltd Sti in Turkey. The device registration started on January 04, 2021.

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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Class IIb
ARTG 352376
Class IIb
Soft-tissue anchor, non-bioabsorbable
ARTG ID: 352376
Good Name: Australian Orthopaedic Fixations Pty Ltd - Soft-tissue anchor, non-bioabsorbable
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Intended Purpose

Suture anchors manufactured from PEEK (Polyethylene Ether Ketone) material and designed for use in repair of ligament ruptures during open or closed surgery. Can be used to re-connect tissue in the shoulder, foot and ankle, elbow and knee.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
352376
Start Date
January 04, 2021
Effective Date
January 04, 2021
Manufacturer
Country
Turkey
Address
Camlica Mah Anadolu Bul R Blok Apt No 20 R/6, Yenimahalle, Ankara