Pure Global

?-TCP Granules (GranOS) - Bone matrix implant, synthetic - ARTG 233701

Access comprehensive regulatory information for ?-TCP Granules (GranOS) - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 233701 and sponsored by Pureplay Orthopaedics, manufactured by TCM Associates Limited in United Kingdom. The device registration started on February 12, 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
ARTG 233701
Class III
?-TCP Granules (GranOS) - Bone matrix implant, synthetic
ARTG ID: 233701
Good Name: Pureplay Orthopaedics - ?-TCP Granules (GranOS) - Bone matrix implant, synthetic
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Intended Purpose

GranOS is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or augmenting bony voids or gaps that are not intrinsic to the stability of the bone structure i.e. subjected to either low load or compressive loading. If osseous defects are intrinsic to the stability and integrity of the skeleton, mechanical stability must be addressed prior to use.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
233701
Start Date
February 12, 2015
Effective Date
February 12, 2015
Manufacturer
Country
United Kingdom
Address
3 Hillgrove Business Park Nazeing Road, Nazeing, Essex, EN9 2HB