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Global Orthopaedic Technology is very pleased to announce that the Australian Therapeutic Goods Authority has conferred a CE mark on our flagship product the RBK Total Knee System.
The CE mark will allow us unimpeded entry into the European markets, Japan, China and Canada where we have surgeons already committed to its use. The CE mark process was long and arduous despite an exemplary technical file and excellent clinical results. Global acknowledges that the TGA have only recently embraced the CE conformity assessment process and takes this opportunity to thank them for their thorough scrutiny of our file. We were happy to assist the TGA, in any way, to make their review of this type of submission more streamlined.
To this end, we must congratulate Mr. Ricardo Lucchini who, in concert with a number of his Global colleagues, prepared a report with electronically attached files, hyperlinks and an indexation system second to none. Ric (as he is affectionately known) is even hoping to have an interactive multimedia introduction covering the entire file for future submissions.
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