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Exabone HA/TCP - Graft, bone, synthetic

Access comprehensive regulatory information for Exabone HA/TCP - Graft, bone, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by LMT Surgical Pty Ltd, manufactured by Exabone GmbH in Switzerland. The device registration started on January 21, 2015.

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 III
Class III
Exabone HA/TCP - Graft, bone, synthetic
Australia TGA ARTG Registered Device
Good Name: LMT Surgical Pty Ltd - Exabone HA/TCP - Graft, bone, synthetic
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Intended Purpose

Intended to be used as a scaffold to support the ingrowth of adjacent viable bone in defects that are not intrinsic to the stability of the bone structure. These defects may be located in the extremities, spine, pelvis or cranium. EXABONE HA/TCP may also be used in the same manner during hip surgery and hip revision surgery. The blocks or granules may be gently pressed into the defect by hand or shaped to more accurately fit the defect, and may also be soaked with bone marrow aspirate prior to implantation.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 21, 2015
Effective Date
January 21, 2015
Manufacturer
Country
Switzerland
Address
Route de Saint-Cergue14, Nyon, CH1260