uDesis Gel - Bone matrix implant, synthetic
Access comprehensive regulatory information for uDesis Gel - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Joy Surgical Pty Ltd, manufactured by TCM Associates Limited in United Kingdom. The device registration started on December 20, 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.
Indication for Use: uDesis is intended to be used to fill bony voids occurring in the skeletal system which are not intrinsic to the stability of the bone structure, it is used in place of corticocancellous, or cancellous allograft 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