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MectaGlass Injectable Putty - Graft, bone, synthetic - ARTG 452645

Access comprehensive regulatory information for MectaGlass Injectable Putty - Graft, bone, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 452645 and sponsored by Medacta Australia Pty Ltd, manufactured by Noraker in France. The device registration started on June 18, 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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Class III
ARTG 452645
Class III
MectaGlass Injectable Putty - Graft, bone, synthetic
ARTG ID: 452645
Good Name: Medacta Australia Pty Ltd - MectaGlass Injectable Putty - Graft, bone, synthetic
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Intended Purpose

MectaGlass Injectable Putty is a synthetic, resorbable, biocompatible and bioactive substitute device, intended for the filling, reconstruction and / or fusion of bone defects or gaps of the skeletal system, in orthopedic surgery, spine, cranio-maxillofacial surgery and ENT. It is indicated in case of loss or lack of bone substance for bone defects of traumatic, pathological or surgical origin when autologous solutions are not applicable or sufficient in orthopedics, neurosurgery, cranio maxillo facial and otorhinolaryngology surgery in children and adult population: - Fusion or reconstruction of deformities and degenerative diseases in spine - Fusion or reconstruction of deformities and degenerative bone pathologies in orthopedic - Filling and reconstruction of bone defects due to resection of tumors, cyst or infection and in case of prosthetic revision - Filling after surgical bone defect (donor sites after removal of autograft, trepanation,โ€ฆ) - Filling after removal of cholesteatoma - Filling and reconstruction due to maxilla and periodontium pathologies (in adult only).

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
452645
Start Date
June 18, 2024
Effective Date
June 18, 2024
Manufacturer
Country
France
Address
60 Avenue Rockefellar, Lyon, France, 69008