NanoBone Granulate - Bone matrix implant, synthetic - ARTG 281251
Access comprehensive regulatory information for NanoBone Granulate - 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 281251 and sponsored by My Biologics Pty Ltd, manufactured by Artoss GmbH in Germany. The device registration started on October 11, 2016.
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.
NanoBone® synthetic bone void filler is intended to be used for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. NanoBone® is also intended to fill, augment, and / or reconstruct maxillofacial osseous bone defects, including periodontal, oral, and craniomaxillofacial applications. NanoBone® is indicated to be placed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a synthetic bone void filler that resorbs and is replaced by bone during the healing process. This medical device is not intended to be used where high tensile, compressive, torsion and/or bending strength are required except when the surroundings have been properly secured mechanically with rigid fixation hardware.