uDesis Gel synthetic bone substitute - Bone matrix implant, synthetic - ARTG 353248
Access comprehensive regulatory information for uDesis Gel synthetic bone substitute - 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 353248 and sponsored by Precision Surgical Pty Ltd, manufactured by TCM Associates Limited in United Kingdom. The device registration started on January 18, 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.
uDesis Gel is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or augmenting bone void or gaps that are not intrinsic to the stability of the bone structure, i.e. subjected to low load or compressive loading. If osseous defects are intrinsic to the stability or integrity of the skeleton, mechanical stability must be addressed prior to use. uDesis indicated for use in place of corticocancellous, or cancellous or autograft bone. Typical applications for bone substitutes are: Bone void filling following surgery, typical surgical techniques include: . Small void filling, e.g. after removal of a bone tumor or following bone fracture reduction or in osteotomies. . Spinal fusion, where an interbody cage or mechanical fixation is used concurrently to relieve the graft site from load. . Osseous defects created from traumatic injury to the bone. . Bone void filling following removal of a cyst or tumor.